Clinical trial NCT03772678
Conditions: None - Study is to Determine Safety in Healthy Participants
Sponsor: Arch Biopartners Inc.
Start date: 2019-06-27; Completion date: 2020-03-31
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants

Detailed description:

Arms: arm 1: 0.9% Saline For SAD and MAD arms. arm 2: LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days. arm 3: LSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen. arm 4: LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days.
Interventions: intervention 1: LSALT peptide intervention 2: 0.9% Saline
Intervention descriptions: intervention 1: novel 16 amino acid peptide intervention 2: saline

Protocol documents:
ICF_002.pdf: 
LSALT Peptide (AB001) 
Arch Biopartners 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample Consent Forms 
 
Confidential 
Page 1 of 5 
Final 1.0 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample 
Consent Forms 
 
Table of Contents 
List of IEC/IRB 
Participant Information and Consent Form - Part 1 Low Dose Version 2.0 dated 06-JUN-2019 
Participant Information and Consent Form - Part 2 SAD Version 2.0 dated 04-JUN-2019 
Participant Information and Consent Form - Part 3 MAD Version 2.0 dated 06-JUN-2019 
 


LSALT Peptide (AB001) 
Arch Biopartners 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample Consent Forms 
 
Confidential 
Page 2 of 5 
Final 1.0 
List of IEC/IRB 
 
Site 
IEC/IRB 
Chair 
Nucleus Network Limited 
(Australia) 
Alfred Health, Alfred 
Hospital Human Research 
Ethics Committee 
55 Commercial Road 
Melbourne, VIC 
Australia, 3004 
Professor John J. McNeil 
 


LSALT Peptide (AB001) 
Arch Biopartners 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample Consent Forms 
 
Confidential 
Page 3 of 5 
Final 1.0 
Participant Information and Consent Form - Part 1 Low Dose Version 2.0 dated 06-JUN-
2019 


Study Drug- LSALT peptide 
 
AB001 Part 1 Low Dose PICF V2.0_06 June 2019  
 
Page 1 of 21 
 
Participant Information and Consent Form 
Low Dose Cohort 
 
Alfred Project Number: 
64/19 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and 
pharmacokinetic profile of LSALT Peptide in healthy participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc  
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 
PART 1 - What does my participation involve? 
 
1. 
Introduction 
You are invited to take part in this research study because you are a healthy male/female aged 18-
55 years old who potentially meets the study participation requirements.  
This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in 
your blood) of a single/multiple intravenous (IV) infusion (into the vein) doses of a new drug called 
LSALT.  
This Participant Information and Consent Form (PICF) tells you about the research study. It also 
explains the tests and treatments that will be completed during study participation. This information 
is given to you to help you decide if you want to take part in this research study. Please read this 
information carefully and ask the study doctor questions about anything that you don’t understand 
or want to know more about before deciding whether or not you want to take part. If you wish to do 
so, please take the time to talk about it with a relative, friend or your local doctor before deciding  
to participate. 
Once you understand what the study is about and if you agree to take part in it, you will be asked 
to sign a Consent Form. By signing the Consent Form, you indicate that you understand the 
information and that you give your consent to participate in the research study.  
Your information regarding participation in the study will be provided to your usual doctor if you opt 
to provide their contact details to study staff. 
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. 


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Page 2 of 21 
If you decide you want to take part in the research study, you will be asked to sign the consent 
section. By signing it you are telling us that you: 
• 
understand the information you have read; 
• 
consent to take part in the research study; 
• 
consent to follow the study requirements 
• 
consent to have the tests and treatments that are described; 
• 
consent to follow the study requirements and to keep follow-up appointments that are 
described; 
• 
consent to the use of your personal and health information as described. 
A description of this clinical trial is available on www.clinicaltrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results after 
the trial is completed. You can search this website at any time. 
You will be given a signed copy of the Participant Information and Consent Form to keep. 
 
2. 
What is the purpose of this research? 
Arch Biopartners Inc is developing the study drug LSALT peptide as a potential new treatment for 
acute kidney injury. Acute kidney injury is a common disease in people who are hospitalized or 
undergoing major surgery. Acute kidney injury is a serious complication that increases the risk of 
death and other serious health problems. Thus preventing acute kidney injury is desirable and may 
improve the health of people at risk of this complication. Currently, there are no specific treatments 
to prevent acute kidney injury. The LSALT peptide is a drug that is being developed to prevent 
acute kidney injury in people. LSALT works to prevent immune cells entering damaged parts of the 
body such as the kidneys. Preventing immune cells entering these parts of the body could 
potentially reduce the amount of damage from insults such as blockage of the blood supply. In 
animal studies, the LSALT peptide has been shown to be very effective in protecting the kidney. In 
order to start treating kidney disease with the LSALT peptide in humans, researchers must first 
understand the safety profile of the drug and what happens to the drug once it is injected. 
The purpose of this research is to determine the safety and behaviour of  LSALT peptide  in people. 
If the LSALT peptide is found to be safe, this will lead to future clinical trials testing the effectiveness 
of the drug in preventing acute kidney injury in people. This research will also lead to the design of 
new and improved versions of the LSALT peptide 
Medications, drugs and devices must be approved for use by the Australian Federal Government; 
the Therapeutic Goods Administration (TGA). LSALT peptide has not been approved for marketing 
by the TGA in Australia (and is not yet approved anywhere else in the world). Therefore, the use 
of LSALT peptide in this study is experimental. 
LSALT peptide has been tested in animals and found to be safe at doses much higher than planned 
in this study. LSALT peptide has never been tested in humans. Although unlikely, there is a risk 
of death in first in human studies such as this study. 
In other studies, some unexpected serious, life-threatening side effects have occurred following 
the administration of new experimental treatments. It is unknown, however unlikely, whether some 
unexpected serious, life threatening side effects could occur with LSALT peptide. You will be 
monitored closely for them and treated if they occur.  
This study is being conducted at the Centre for Clinical Studies at Nucleus Network Pty. Ltd., 
Melbourne, Australia. The Clinical Research Organisation involved in monitoring the study is 
Syneos health.  Arch Biopartners Inc is the international company sponsoring this study along with 
Arch Clinical Pty Ltd  who is the Australian Company.  
 
 


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AB001 Part 1 Low Dose PICF V2.0_06 June 2019  
 
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3. 
What does participation in this research involve? 
Before you begin the study, you will be given detailed information about LSALT peptide, the study, 
and any other relevant information by research staff. You are encouraged to ask questions until 
you are sure that you fully understand the nature of and requirements of the study. 
If you decide to be assessed for inclusion in the study, you will be asked to visit the Centre for 
Clinical Studies for an initial assessment visit (screening visit). Before any procedures are 
undertaken, you will be asked to sign a consent form. You will then have some tests to check that 
the study is suitable for you. The screening visit may take between 1 and 2 hours. 
This study will enrol approximately 52 participants into 3 parts; 
• 
Part 1- Low dose Cohort- 4 participants will be dosed with a low dose of the study drug 
(0.01mg, 0.1mg, 0.3mg and 0.5mg), 1 dose of increasing strength for each participant. 
Participants will be dosed on Day 1 with a single dose of the study drug and will stay in the 
unit for an inpatient stay of 2 days. You are then required to return for a single follow up 
visit. 
• 
Part 2- Single Ascending dose Cohort- 24 participants will be split into 3 cohorts (groups) 
of 8 and will be dosed with a single dose of the study drug (1mg, 2.5mg and 5mg) during 
an inpatient stay of 2 days. You are then required to return for 2 separate follow up visits 
• 
Part 3- Multiple Ascending dose Cohort- 16 participants will be split in 2 cohorts (groups) 
of 8. Participants will be dosed with the study drug once or twice per day for 3 days with 
an inpatient stay of 4 nights. You are then required to return for 3 separate follow up visits. 
This PICF will only outline the requirements of Part 1 of the study, the Low Dose cohort.  
Part 1 will enrol 4 participants in a low dose cohort. The first participant will be given the lowest 
strength study drug, monitored for 24 hours and then discharged. Once discharged, the participant 
will have to return for a follow up visit to ensure there are no safety concerns. The results will be 
reviewed, then the next low dose participant (participant 2) will be admitted. This pattern will 
continue for all 4 low doses. 
 
Admission  
Dose 
Discharge 
Follow up 
Participant 1 
Day -1 
0.01mg 
Day 2 
Day 4 
Participant 2 
Day 4 
0.1mg 
Day 6 
Day 8 
Participant 3 
Day 8 
0.3mg 
Day 10 
Day 12 
Participant 4 
Day 12 
0.5mg 
Day 14 
Day 16 
 
As this is a dose escalation study, the first participant enrolled will receive the lowest dose and 
once it is considered to be safe, the next participant will be enrolled to receive the next higher dose. 
Dose escalation will only proceed following review of all available safety data by the Principal 
Investigator in consultation with the sponsor and there is confirmation that it is safe to continue with 
the next higher dose strength in the next group. The study can be stopped at any time, based on 
evaluation of the side effects of the study medication. 
The dose levels planned for this part of the study range from 0.01 to 0.5 milligrams. You will be 
informed of the exact dose when you check in to the clinical unit . 
 
Study sequence: Your total participation in the study will consist of approximately 5 weeks as 
follows: 
• 
Screening visit: will occur within 29 days of your dose. You will undergo assessments to 
determine if you are eligible for the study 


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• 
Admission and treatment period: in patient period of 2 nights 
• 
Follow up period: a single out patient follow up visit is required  
 
Below is a picture outlining an example schedule for the study (Participant 1): 
Please see above table for requirements for each participant
 
If you decide to be assessed for inclusion into the study, you will be asked to visit the Centre for 
Clinical Studies for the screening visit. The  screening visit may take between 1 and 2 hours.  
 
Screening visit (between Day -29 to Day -2) 
After reading this information sheet and if you agree to participate in the study, you will be asked 
to sign the attached consent form. The study doctor will perform a medical examination to ensure 
that it is appropriate for you to be part of the study. You will undergo the following assessments: 
• 
You will be asked about your current health status and about your medical history, 
including all medications, over-the-counter and herbal medications that you have been, and 
are currently taking. 
• 
You will be asked some personal details about yourself, including your date of birth. 
• 
You will be asked about your alcohol history and you will undergo an alcohol breath test.  
• 
You will be asked to provide a urine sample to assess your general health and to test for 
medications of addiction as listed below: 
- 
to test for nicotinine level (to test if you have smoked cigarettes) 
o to test for drugs of addiction (such as Methamphetamine, Cocaine, Cannabinoids, 
Opiates, 
Phencyclidine, 
Barbiturates, 
Benzodiazepines, 
Methadone, 
and 
Amphetamine). This is a study requirement and the results will remain confidential. 
The tests may reveal that you have previously used illegal medications. That 
information will be stored in a re-identified (or coded) format. If the Centre for Clinical 
Studies is required to disclose that information, it may be used against you in legal 
proceedings or otherwise. If you test positive for any of these substances, you will 
be excluded from further participation in this study. 
• 
Your vital signs such as blood pressure, pulse rate and oral body temperature will be 
measured.  
• 
You will have a full physical examination (PE), your height and weight will be measured 
to determine your body mass index (BMI). 
• 
You will have electrocardiograms (ECG) (recording of your heart’s electrical activity and 
rhythm).   
• 
Blood sample (approximately 25mL / 5 teaspoons) will be collected for general safety 
assessemnts and to screen for HIV (AIDS virus), and hepatitis B and C. This is because 
the study doctors need to know about your general health and the health of your immune 
system. You will have to be fasting 8 hours for screening blood collection. 
o You will receive information and counselling before the HIV and hepatitis tests. If a 
test shows you have HIV or hepatitis you will not be included in this study, but you 
Screening: 
within 29 days
Admit: Day -1
Dose: Day 1
Discharge: Day 2
Follow up
Day 4


Study Drug- LSALT peptide 
 
AB001 Part 1 Low Dose PICF V2.0_06 June 2019  
 
Page 5 of 21 
will have follow-up counselling and medical advice. If your test results are positive, 
the researchers are required by law to notify the Victorian government. Signing the 
consent form means you agree to have this testing. It will not be done without your 
consent. 
• 
Pregnancy Test: from your blood sample, a pregnancy test will be performed.  
• 
Chest x-ray: you will have a chest x-ray at a local clinc since the LSALT peptide could 
affect your lungs. You will be provided with details about where to go for this assessment 
when appropriate.  
If for any reason, the trial is found to not be suitable for you, staff from the Centre for Clinical Studies 
will contact you and provide follow-up treatment advice where applicable. 
 
Treatment and Follow-up Period 
If you are eligible to enter the study, you will be admitted to the clinical unit the day before the 
planned dosing day. You will undergo a number of procedures to confirm your suitability for 
participation in the trial (see table below). 
To ensure sufficient number of participants are available for dosing, additional volunteers called 
‘alternates’ will be recruited and admitted to the clinical unit. If you are an alternate, you may be 
asked to participate in the study if someone is not included in the dosing group. You will be informed 
if you are an alternate  before treatment is given. 
The following day, the study drug will be administered as an IV infusion over a period of 
approximately 2 hours, or as determined by the PI and the safety monitoring committee.    
On the morning of your first day in the clinical unit, a cannula will be inserted into a vein in your 
arm. This is a small, flexible tube which will allow blood to be collected easily throughout your unit 
stay and prevents the need for repeated needles to be inserted in your vein to collect each sample. 
The location of the cannula may need to be repositioned if required. 
During the occasions that you are required to stay overnight, you will be provided meals. You will 
need to have fasted from all food and drink except water for at least 8 hours before providing blood 
samples. 
You will undergo the following procedures at various time points during the study, the table of 
assessments below outlines when these events will take place:  
 
• 
Vital signs: Oral temperature, pulse rate and blood pressure will be measured. 
• 
12-Lead Electrocardiogram (ECG): will be performed to assess your heart rhythm. 
• 
Physical Examination: will be performed to assess your general health. This will include 
measuring your body weight. 
• 
Safety blood and urine samples: approximately 25 ml (approx. 4 teaspoons) of blood and 
a urine sample will be collected to assess your general health. When you check in, the urine 
sample will also be collected to test for drugs of addiction and to test if you have smoked. 
A positive test will exclude you from further participation in the trial. A pregnancy test will 
also be performed from your urine sample a number of times during the study. 
• 
Alcohol breath test: You will undergo an alcohol breath test when you check into the 
clinical unit to see if you have been drinking any alcohol in the past 24 hours. A positive 
test will exclude you from further participation in the trial. 
• 
Study drug administration: The study drug will be administered as an IV infusion over 
approximately 2 hours.  
• 
Pharmacokinetic (PK) samples: will be collected to measure the amount of LSALT 
peptide in your blood, the break down products and to assess the effect it has on your body. 
Approximately 5 mL of blood (approx. 1 teaspoon) will be collected at various time points 
during a study visit.  


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Page 6 of 21 
• 
Concomitant Medication review: you will be asked if you have recently taken any 
medications.  
• 
Adverse Events: You will be asked about how you are feeling (whether you feel alright, 
different from normal or unwell) at regular intervals, please tell a study team member if you 
have any changes in your health or concerns. 
You will be discharged from the clinical unit once all study procedures are complete and the clinical 
staff sees no changes in your health which would prevent your discharge from the clinical unit.  
 
Follow up visits 
You will be reqired to return to the study center for a single follow up visit 2 days after your 
discharge.  
 
The study doctor will ask you to return to the research unit on the follow up day and may ask you 
to return after this period, if he/she feels it is necessary. In the event it is necessary to further 
evaluate the safety or effects of the medication, it may be necessary to have access to additional 
information about your health status. Your study doctor may attempt to obtain study-related 
information about your health from you or from other sources, including your primary care 
physician. This may include contacting you again by phone or letter. 
 


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The table below outlines the assessments that will be performed during the low dose cohort: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Key; LFT= liver function tests, INR/PTT=blood clotting ability, B-hCG= pregnancy test  
 
 
Participant 
 
1 
2 
3 
4 
Study Day 
Screening 
-29 to -2 
-1 
1 
2 
4 
4 
5 
6 
8 
8 
9 
10 
12 
12 
13 
14 
16 
In patient period 
 
X 
X 
 
 
X 
X 
 
 
X 
X 
 
 
X 
X 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Exam 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Alcohol Breath test 
X 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Drugs of abuse testing (urine sample) 
X 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Urinalysis 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Complete blood count (CBC) 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Chemistry 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Creatinine/eGFR 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
LFTs  blood sample for (blood clotting ability) 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
INR/PTT 
X 
 
 
X 
X 
 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
Chest X-ray 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Electrocardiogram ECG 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
 
X 
X 
X 
 
X 
B-hCG  blood sample for pregnancy test 
X 
X 
 
 
X 
X 
 
 
X 
X 
 
 
X 
X 
 
 
X 
Adverse Event 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
LSALT Administration 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
Discharge from unit 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Follow up 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 


 
 
 
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4. 
What do I have to do? 
It is important for your own safety that you inform the study doctor or staff of your complete 
medical history and all medications, supplements, and/or herbal preparations that you have 
taken within the past 6 months or are currently taking. If you have any health problems, please 
notify your study doctor immediately. As mentioned earlier in this document, if you notice any 
changes in your health or have concerns during your participation in the study, also inform 
your study doctor or study staff as soon as possible. So long as you continue to participate, 
you should take the study drug as directed. You must always follow the instructions of the 
study doctor and staff. 
Please note that in the days leading up to your admission to the clinical unit, there are a few 
things you must avoid to be included in the study:  
• 
You should not have participated in other clinical trials within 1 month before signing 
this consent form. 
• 
You should not have donated blood within 60 days before admission into the unit. 
• 
You will be asked to come to the Centre for Clinical Studies in fasting condition (no 
consumption of any food or drinks, with the exception of water, during the 8 hours prior 
to arrival), at admission to the clinical unit and at the follow-up visit. During your stay 
in the clinical unit, you should follow the instructions of the study staff concerning your 
intake of food and beverages 
• 
Please do not take any prescription medication for 2 weeks prior to your admission to 
the clinical unit.  
• 
Please do not take any over the counter medication for 7 days prior to admission. 
Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day 
respectively) are acceptable. Routine vitamins and supplements are permissible at the 
discretion of the investigator. Please ask if you have any questions.  
• 
Social and light smokers (up to 10 cigarettes per day) are allowed to enter the study, 
however they must agree and be able to abstain from smoking for the full inpatient 
period.  
• 
Please do not consume any caffeine, quinine (tonic water) and xanthine containing 
beverages (tea, coffee, cola, chocolate) for 48 hours prior to your screening 
appointment and 48 hours prior to your admission to the clinical unit. Consumption of 
quinine, caffeine and xanthine containing beverages is not allowed throughout the 
clinical stay. Please ask your study doctor if you have any questions regarding the 
above restrictions.  
• 
Please do not consume alcohol for 48 hours prior to your admission to the clinical unit 
until after your final visit.  
• 
Please do not perform any strenuous exercise for 2 days prior to your admission to the 
clinical unit and until after your final visit. 
• 
You should not have donated blood in the 2 months prior to starting the study and 
should refrain from donating blood during the study and within 2 months after your final 
visit. If you donate blood after this period, you must inform donor centre staff that you 
have recently been involved in a clinical study.  
Please note that you will not be allowed to smoke while at the study centre. 
In case of emergency, you must be easily contactable by phone and/or email. You will be 
given a Participant Wallet Card which contains emergency contact information and information 
about your study commitments. You must carry the Participant Wallet Card with you at all 
times until the end of the study. 


 
 
 
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5. 
Other relevant information about the research study 
This study is being conducted at the Centre for Clinical Studies in Australia. There are no 
researchers from other organisations working in collaboration. 
A representative of Arch Biopartners Inc (study sponsor) may be present for inspections in the 
unit during the study.  
 
6. 
Do I have to take part in this research study? 
Participation in any research study is voluntary. If you do not wish to take part, you don’t have 
to. If you decide to take part and later change your mind, you are free to withdraw from the 
study at any time without providing any reason. Your study doctor may ask you the reason for 
your withdrawal, you can answer or not.  
Your decision whether to take part or not, or to take part and then withdraw, will not affect your 
relationship with the Centre for Clinical Studies and will not involve any penalty or loss of 
benefits to which you would be otherwise entitled. Should you withdraw from the study before 
the final visit you may receive a partial payment according to the number of visits you have 
attended. 
Before you make your decision, a member of the research team will be available so that you 
can ask any questions you have about the research study. You can ask for any information 
you want. Sign the Consent Form only if you agree to participate and only after you have had 
a chance to ask your questions and have received satisfactory answers. 
 
7. 
What are the alternatives to participation? 
Since this study is intended only to evaluate the safety, tolerability and pharmacokinetics of 
LSALT peptide, your alternative to be a volunteer in this study is to choose not to participate 
in the study. 
 
8. 
What are the possible benefits of taking part? 
If you agree to take part in this study, there will be no direct benefit to you. However, your 
participation in this study may help develop important scientific knowledge that could 
contribute to the development of this medication for kidney diseases. We hope the information 
learned from this study will benefit others in the future. 
 
9. 
What are the possible risks and disadvantages of taking part? 
LSALT peptide is an experimental medication, therefore the risks to human participants have 
not been fully evaluated. 
Medical treatments often cause side effects. You may have none, some or all of the effects 
listed below, and they may be mild, moderate or severe. If you have any of these side effects, 
or are worried about them, talk with a study doctor. Your doctor and study staff will also be 
watching you closely for side effects. 
Many side effects go away shortly after treatment ends. However, sometimes side effects can 
be serious, long lasting or permanent. If a severe side effect or reaction occurs, your doctor 
may need to stop your treatment. Tell your study doctor or site staff if you notice any changes 
in your health or have concerns.  Your study doctor will discuss the best way of managing any 
side effects with you. 


 
 
 
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Page 10 of 21 
There may also be side effects that are not expected or are not known that may be serious. 
Tell your doctor immediately about any new or unusual symptoms or changes in your health 
that you become aware of. The treatment of the side effects will depend on the type and 
severity of the symptom(s). 
If during screening or participation in this research study a previously unknown medical 
condition is discovered the study doctor will discuss: 
• 
whether you are eligible for study participation  
• 
if you require referral to your usual physician or to a specialist 
 
Risks of Study Drug: 
Currently, the risks of LSALT peptide in humans are unknown. There may be side effects 
related to the infusion of the drug such as lightheadedness, nausea or an allergic reaction. In 
animals, these infusion related side effects were easily treated with anti-histamines. However, 
the drug will be given at much lower doses than the amount administered to animals, and will 
be infused very slowly to minimize these side effects.There is also a small risk that you may 
develop antibodies against the the LSALT peptide which may cause some medical problems, 
especially if you were to receive the drug again in the future. 
Blood Draw/ Cannula Insertion Risks: 
You may have pain or bruising at the site where blood is drawn or a cannula (a temporary 
small plastic tube) is inserted. An infection at the site of blood draws or cannula insertion is 
also possible. The insertion of the cannula (small plastic tube) or the drawing of blood may be 
associated with some pain. Possible side effects from blood drawing include faintness, 
inflammation of the vein, pain, bruising or bleeding at the site of puncture. These will normally 
disappear a few days after the procedure.  
 
Blood Pressure Measurement Risks: 
There is no risk to your health when having your blood pressure tested. You may experience 
some feeling on discomfort as the cuff inflates and squeezes your arm, but it should only last 
a few seconds. Sometimes, there are tiny red spots that appear after the test just below the 
location of the cuff, they should be painless.  
 
Electrocardiogram (ECG) risks: 
The ECG test is a recording of the electrical activity of your heart. The sticky pads used may 
be cold when applied and sometimes cause some discomfort such as redness or itching. If 
there is hair in the area where patches need to be applied, this area will be shaved in order to 
complete the ECG. Shaving may result in irritation. 
Risks of Chest X-ray (Radiation Risk)This research study involves exposure to a very small 
amount of radiation. As part of everyday living, everyone is exposed to naturally occurring 
background radiation and receives a dose of about 2 millisieverts (mSv) each year. The 
effective dose from this study is about 0.02 mSv. At this dose level, no harmful effects of 
radiation have been demonstrated as any effect is too small to measure. The risk is believed 
to be minimal.  
Have you been involved in any other research studies that involve radiation? If so, please tell 
us. Please keep information contained within the Patient Information and Consent Form about 
your exposure to radiation in this study, including the radiation dose, for at least five years. 
You will be required to provide this information to researchers of any future research projects 
involving exposure to radiation. 
Allergic Reaction Risks: 


 
 
 
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There is a risk of allergic reaction. If you have a very serious allergic reaction, you may be at 
risk of death.  
Symptoms may include difficulty in breathing, dizziness, itching, swelling of the lips, tongue or 
throat, coughing, rash. 
In general, most symptoms are manageable. They are mild to moderate in severity. But life-
threatening reactions may occur at any drug dose. If you believe you are having a serious 
allergic reaction, you should seek emergency medical assistance immediately. 
Please notify the study doctor immediately if you experience any of these symptoms. Some 
symptoms of allergic reactions are: 
• 
Rash 
• 
Wheezing and difficulty breathing 
• 
Dizziness and fainting 
• 
Swelling around the mouth, throat or eyes 
• 
Fast pulse 
• 
Sweating 
You will be monitored very carefully for any signs or symptoms that you may be having an 
allergic reaction and appropriate care will be taken by the study doctor and nursing staff.  
If you do not understand what some of these side effects or risks mean, ask the study doctor 
or the study staff to explain them to you. 
Pregnancy Risk:  
The risks of the study drug to an unborn child or nursing infant are unknown and may be 
hazardous. It is important that you use the appropriate forms of birth control as described 
below: 
If you are male, you must be either vasectomised, sexually abstinent (when this is in line with 
your preferred and usual lifestyle) or agree to use a condom. If you use a condom and your 
partner is of childbearing potential, she must use another method of contraception resulting in 
a highly effective method of birth control for the full duration of the study and for 3 months after 
the last dose of study drug. 
 
If you are female and of childbearing potential, you must also use a double barrier method of 
contraception for at least 90 days after the last dose of study drug.  
 
Double barrier contraception is defined as a condom AND one of the following; 
• 
Birth control pills (The Pill) 
• 
Birth Control Patch (e.g. Ortho Evra) 
• 
NuvaRing® 
• 
Depot or injectable birth control 
• 
IUD (Intra Uterine Device) 
• 
Documented evidence of surgical sterilization at least 6 months prior to screening 
visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. 
 
Please ask you study doctor if you have any questions regarding the forms of birth 
control that must be used while participating in this study. 
If you are male, you must not donate sperm for at least 90 days after last dose of study drug. 
If you/your partner becomes pregnant during the study or up to 90 days after the last dose of 
study drug, please tell your study doctor or staff immediately as we would like to request 
permission to follow this pregnancy and its outcome. The study doctor will also report the 
pregnancy to the Human Research Ethics Committee and to the study Sponsor.  


 
 
 
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Allowing the pregnancy and outcome to be followed is optional. If your partner agrees to have 
this pregnancy followed, then she will be asked to sign a separate Pregnancy Follow-Up 
Participant Information and Consent Form. The information collected is similar to that which 
would be routinely collected during a typical pregnancy consultation. The consultation will be 
done in person at the Centre for Clinical Studies, and/or by telephone.  
In addition, she will be asked to notify the study doctor about the outcome of the pregnancy. 
If she forgets, she will be contacted to obtain this information. This outcome data collected 
includes: pregnancy complications and outcome, birth weight, birth defects (if any), and 
additional factors that may have had an impact on the outcome of the pregnancy (drugs, 
infections, family history etc.).  
The study doctor may also need to contact the gynecologist of your partner. 
 
10. 
What will happen to my test samples? 
By consenting to take part in this study, you also consent to the collection and testing of your 
urine and blood samples for this research. The total volume of blood taken for the entire study 
is approximately 80ml (approx. 5 tablespoons). For comparison, a standard blood donation is 
approximately 470mL (approx. 2 cups). Additional blood samples may also be collected for 
safety reasons.  
The blood and urine samples collected for the assessment of your health status (e.g. liver and 
kidney function tests) will be processed by a local pathology laboratory. These samples will 
be labelled with your unique study participant number, your initials and date of birth, and will 
not contain any information that can identify you personally. These samples will be destroyed 
following analysis. 
This research project involves the collection of information about your use of drugs and 
alcohol. Participation in the research project includes blood and urine analysis to determine 
the presence of drugs such as amphetamines, methamphetamines, benzodiazepines, 
barbiturates, marijuana, cocaine, PCP, methadone, opioids (narcotics). The test may reveal 
that you have previously used illegal drugs. That information will be stored in a re-identifiable 
(or coded) format. This is a study requirement and the results will remain confidential. In the 
event that the Centre for Clinical Studies is required to disclose that information, it may be 
used against you in legal proceedings or otherwise. If you test positive for any drugs of 
addiction, you will not be able to participate in this study. 
You will receive information and counselling before the HIV and hepatitis tests. If a test shows 
you have HIV or hepatitis you will not be included in this study, but you will have follow-up 
counselling and medical advice. If your test results are positive, the researchers are required 
by law to notify the Victorian government. Signing the consent form means you agree to have 
this testing. It will not be done without your consent. 
Blood samples taken for pharmacokinetics will be sent to various Sponsor-approved 
laboratories in Canada. These samples will be labelled with your unique study participant 
number and will not contain any information that can identify you personally. These samples 
will be stored during the study at a secure premise and the samples will be destroyed following 
analysis at the end of the study. 
 
11. 
What if new information arises during this research study? 
Sometimes during the course of a research study, new information becomes available about 
the treatment that is being studied. If this happens, your study doctor will tell you about it and 
discuss with you whether you want to continue in the research study. If you decide to withdraw, 
your study doctor will make arrangements for your regular health care to continue. If you 
decide to continue in the research study you will be asked to sign an updated consent form. 


 
 
 
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Also, on receiving new information, your study doctor might consider it to be in your best 
interests to withdraw you from the research study. If this happens, he/she will explain the 
reasons and arrange for your regular health care to continue. 
 
12. 
Can I have other treatments during this research study? 
Whilst you are participating in this research study, you are not able to take any medications or 
treatments other than those agreed upon at the start of your participation in the study. It is 
important to tell your study doctor and the study staff, at each clinic visit, about any treatments 
or medications you may have taken, including over-the-counter medications, vitamins or 
herbal remedies, acupuncture or other alternative treatments. 
 
13. 
What if I withdraw from this research study? 
If you decide to withdraw from the study, please notify your study doctor or staff before you 
withdraw. This notice will allow the study doctor to discuss any health risks or special 
requirements linked to withdrawing. 
If you do withdraw your consent during the research study, any information collected on you 
up to the point of withdrawal will be used. Data collected after your withdrawal, if any, may be 
used: 
• If you decide to withdraw from the study, any adverse event not resolved at this time 
will be followed until its resolution by your research doctor to ensure your medical 
follow-up. You may also contact your research doctor if you experience a new adverse 
event. 
• If you withdraw from the study for a reason other than your own decision, your 
research doctor may contact you to request any relevant information and / or 
documentation regarding your medical care. 
• If you withdraw your consent, all your biological sample(s) will be destroyed without 
disclosing your identity. If analysis is required for the study, it will be analysed before 
destroying your samples.   
 
14. 
Could this research be stopped unexpectedly? 
This research study may be stopped unexpectedly for the reasons listed below.   
• 
Unacceptable side effects 
• 
The drug being shown not to be safe 
• 
Decisions made in the commercial interests of the sponsor or by local regulatory/health 
authorities 
• 
If you don’t follow the instructions of the clinical unit staff; or 
• 
If the study doctor decides it is in the best interest of your health and welfare to stop. 
 
15. 
What will happen when the research study ends? 
The study drug will not be available to you following completion of participation.  
The study data will be analysed, and a final report provided to the study doctor, who will share 
the results with you when requested. The disclosure and/or any published results will be 
available to you when requested. It is usual for a number of years to elapse before definitive 


 
 
 
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results of this type of study are available. These may be published in medical journals that are 
available to the public. You should feel free to ask the study staff about this. 
 
Part 2 - How is this study being conducted? 
 
16. 
What will happen to information about me? 
Any information and data obtained/retained in connection with this research study that can 
identify you will remain confidential and will only be used for the purpose of this research study 
and future research related to the pathway being studied and related disease conditions. 
Information about you may be obtained from your health records held at other health services 
for the purpose of this research. By signing the consent form you agree to the study team, 
including Sponsor delegates, accessing health records if they are relevant to your participation 
in this research study to ensure data accuracy. Whilst every effort will be made to keep your 
personal information confidential, the data gathered for this study will also be reviewed by a 
Sponsor delegate. This delegate will have access to your medical records, without violating 
your confidentiality to the extent permitted by local laws and regulations,  to verify the data are 
correct and complete. 
The data collected as part of this research study may be reviewed by representatives of the 
international sponsor, Arch Biopartners Inc, its affiliated companies and/or subcontractors, the 
local sponsor, Arch Clinical Pty Ltd, the Research Ethics Committee of Alfred HREC, by 
authorised representatives of the Australian Therapeutic Goods Administration or other 
regulatory agencies. Information may be transferred to parties in countries (and regions) other 
than Australia including the US, and Europe for these purposes. Syneos Health, Arch 
Biopartners Inc representatives, collaborators and contracted agencies comply with internal 
procedures to protect personal information even in countries whose data privacy laws are less 
strict than those of this country. In all cases when dealing with your personal (coded) 
information. Arch Biopartners Inc, and any of their agents will comply with the Privacy Act 
1988. If you have any concerns on how your information is handled, please feel free to ask a 
member of the study team for more information. 
By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Study Medical Records 
Data from your study medical record will be identifiable and stored in secured offices at the 
Centre for Clinical Studies. Only research team members and authorised representatives from 
the Sponsor, the Ethics Committee or regulatory agencies will have access to your medical 
records. 
You have a right to access and request correction to your information. 
 
Case Report Form (CRF) 
Information you provide us will be recorded in electronic case report forms (CRF).  Your 
information will be coded by your unique study number, your gender and birth date only and 
thus will be considered re-identifiable. The recorded data will be kept in an electronic database 
which will be managed throughout the study by Syneos Health who are monitoring the study. 
Information from these CRFs will form part of the study results, which may be published. A 
copy of the CRF entries and your deidentified study medical record will be kept indefinitely 
with all other study related documents. 


 
 
 
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By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Publications 
A report of the study results may be submitted for publication. In any publication and/or 
presentation, information will be provided in such a way that you cannot be identified, except 
with your permission). 
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you 
have the right to request access to your information collected and stored by the research team. 
You also have the right to request that any information with which you disagree be corrected. 
Please contact the study team member named at the end of this document if you would like 
to access your information. 
If you want to know more about the Centre for Clinical Studies’ approach to privacy or access 
any of your information held by the Centre for Clinical Studies, you can contact Dr Ben Snyder 
at the Centre for Clinical Studies. 
It is desirable that your local doctor be advised of your decision to participate in this research 
study. By signing the consent section, you agree to your local doctor being notified of your 
decision to participate in this research study. 
Information about your participation in this research study may be recorded in your health 
records. 
 
17. 
Complaints and compensation 
If you suffer any injuries or complications because of this research study, you should contact 
the study doctor or study team as soon as possible and you will be assisted with arranging 
appropriate medical treatment. If you are eligible for Medicare, you can receive any medical 
treatment required to treat the injury or complication, free of charge, as a public patient in any 
Australian public hospital. 
There are two avenues that may be available to you for seeking compensation if you suffer an 
injury as a result of your participation in this research study: 
• 
The pharmaceutical industry has set up a compensation process, with which the local 
sponsor of this research study, Arch Biopartners Inc, has agreed to comply. Details of 
this process and conditions are set out in the Medicines Australia Guidelines for 
Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical 
Trial. In accordance with these Guidelines, the sponsor will determine whether to pay 
compensation to you, and if so, how much. The research staff will give you a copy of 
the Guidelines together with this Participant Information and Consent Form. If you have 
any questions about the Guidelines, please contact Dr Ben Snyder on 03 8593 9800. 
• 
You may be able to seek compensation through the courts. 
 
If you are not satisfied with how your personal information has been handled (as laid out in 
the Privacy Act, 1988), then you can make a complaint to the Office of the Australian 
Information Commissioner (OAIC). It is free to lodge a complaint and you do not need a lawyer, 
however if you do decide to hire a lawyer, you must pay for the lawyer yourself. You can 
choose 
to 
withdraw 
your 
complaint 
at 
any 
time. 
Please 
refer 
to 
http://www.oaic.gov.au/privacy/privacy-complaints for more information. 
 


 
 
 
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18 
Who is organising and funding the research? 
This research is being conducted by Arch Biopartners Inc based in Canada and in Australia 
by Arch Clinical Pty Ltd. The Clinical research organisation monitoring the study is Syneos 
Health.  Arch Biopartners Inc may benefit financially from this research study if, for example, 
the study assists to obtain approval for a new drug. 
By taking part in this research study you agree that samples of your blood (or data generated 
from analysis of these materials) may be provided to Arch Biopartners Inc. 
Arch Biopartners Inc may directly or indirectly benefit financially from your samples or from 
knowledge acquired through analysis of your samples. 
If knowledge acquired through this research leads to discoveries that are of commercial value 
to Arch Biopartners Inc, the study doctors or their institutions, there will be no financial benefit 
to you or your family from these discoveries. 
Arch Biopartners Inc, other researchers, or research companies may patent or sell discoveries 
that result from this research. Neither Arch Biopartners Inc nor the study doctor will compensate 
you if this happens. 
Contractors engaged by Arch Biopartners Inc will receive a payment from Arch Biopartners 
Inc for undertaking this research study. 
No member of the research team will receive a personal financial benefit from your 
involvement in this research study (other than their ordinary wages). 
 
19. 
Will I be reimbursed to take part in this research study? 
If you are eligible to enter the study, you will be reimbursed $75.00 for the screening and 
follow-up visits, and at an hourly rate of $12.50 per hour for the in-clinic stay part of this study. 
The total payment for participants who complete the entire study will be $830.00.  
Regardless of whether you withdraw early or complete the study, you will be reimbursed within 
10 business days of the end of study visit via electronic funds transfer directly into your bank 
account. Should you withdraw from the study before the final visit you will receive a partial 
payment according to the number of visits you have attended.  
Reimbursement compensates for your time, travel expenses, parking and inconvenience. This 
reimbursement is not made for undergoing risk nor is it to compensate you for any loss of 
earnings as a result of your participation. 
It is not anticipated that participation in this research study will result in any additional cost to 
you. 
 
20. 
Who has reviewed the research study? 
All research in Australia involving humans is reviewed by an independent group of people 
called a Human Research Ethics Committee (HREC) who make sure that the rights, safety 
and well-being of participants in a study are protected. The ethical aspects of this research 
study have been approved by The Alfred Ethics Committee. 
This study will be carried out according to the National Statement on Ethical Conduct in Human 
Research (March 2007) produced by the National Health and Medical Research Council of 
Australia. This statement has been developed to protect the interests of people who agree to 
participate in human research studies. 
 


 
 
 
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21. 
Further information and who to contact 
The person you may need to contact will depend on the nature of your query. 
If you want any further information concerning this study or if you have any medical problems 
which may be related to your involvement in the study (for example, any side effects), you can 
contact the principal study doctor (Dr Ben Snyder) on 03 8593 9800 or any of the following: 
General Enquiries:  
1800 243 733 
After hours contact (Centre for Clinical Studies) 24 hours 7 days a week 
On-call mobile:  
0429 353 069 
 
For matters relating to research at the site at which you are participating, the details of the 
local site complaints person are: 
 
 
Complaints contact person 
Position 
Complaints 
Email 
complaintsofficer@nucleusnetwork.com.au  
Privacy contact person 
Position 
Privacy Officer 
Email 
privacyofficer@nucleusnetwork.com.au  
 
If you have any complaints about any aspect of the study, the way it is being conducted or 
any questions about being a research participant in general, then you may contact: 
Reviewing HREC approving this research and HREC Executive Officer details 
Please reference the following Alfred Project number:  64/19 
 
 
Reviewing HREC name 
Alfred Hospital Ethics Committee 
Position 
Governance Officer,  
Ethics and Research Governance, Alfred Health 
Telephone 
(03) 9076 3619  
Email 
research@alfred.org.au  


 
 
 
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CONSENT 
Alfred Project Number: 
64/19 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single 
and multiple ascending dose finding study to evaluate the safety 
and pharmacokinetic profile of LSALT Peptide in healthy 
participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 I am 18 years of age or over 
 I have read the Participant Information Sheet, or someone has read it to me in a 
language that I understand. 
 I understand that my involvement in this study may not be of any direct benefit to me. 
 I have had an opportunity to ask questions and I am satisfied with the answers I have 
received. I have been given the name of a person to contact if I have any questions 
during the study. 
 I have been told that no information regarding my medical history will be divulged to 
unauthorised third parties and the results of any tests involving me will not be published 
to reveal my identity. 
 I understand the purposes, procedures and risks of the research described for this 
study. 
 I give permission for my doctors, other health professionals, hospitals or laboratories 
outside this hospital to release information to the Centre for Clinical Studies for the 
purposes of this study. I understand that such information will remain confidential.  
 I freely agree to participate in this research study as described and understand that I 
am free to withdraw at any stage during the study without prejudice to future treatment. 
If I withdraw from the study, I agree that the information collected about me up to the 
point when I withdraw may continue to be processed.  
 I understand that I will be given a signed copy of this document to keep. 
 
 
 
 


 
 
 
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Participant’s Name (printed)  …………………….…Middle Initial..……Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
Witness (only if required) 
Name of Witness to 
Participants signature 
(printed)  …………………….…Middle Initial…..…Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
* Witness is not to be the investigator, a member of the study team or their delegate.  In the event that an 
interpreter is used, the interpreter may not act as a witness to the consent process.  Witness must be 18 years 
or older. 
Declaration by Study Doctor/Senior Researcher 
I have given a verbal explanation of the research study, its procedures and risks and I believe 
that the participant has understood that explanation. 
Study Doctor/Researcher’s 
Name (printed)  ……….………………Middle Initial……..Surname……….……....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
A senior member of the research team must provide the explanation of, and information 
concerning, the research study. 
Note: All parties signing the consent section must date their own signature. 
 
 
 
 
 
 
 


 
 
 
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FORM FOR WITHDRAWAL OF PARTICIPATION 
Alfred Project 
Number: 
64/19 
Protocol 
Number: 
AB001 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and 
pharmacokinetic profile of LSALT Peptide in healthy participants 
Test Drug 
Code: 
LSALT Peptide 
International 
Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal 
Investigator: 
Dr Ben Snyder 
Location: Centre for Clinical Studies 
 
Declaration by Participant 
I wish to withdraw from participation in the above research study and understand that such 
withdrawal will not affect my routine treatment, my relationship with those treating me or my 
relationship with the Centre for Clinical Studies. 
Participant’s Name (printed)  ……………………….Middle Initial…..…Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Study Doctor to include a description of the circumstances for withdrawal, if provided by the 
participant. 
 
 
 
Declaration by Study Doctor 
I have given a verbal explanation of the implications of withdrawal from the research study 
and I believe that the participant has understood that explanation. 
 
 


 
 
 
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Study Doctor/Researcher’s 
Name (printed)  ……………….………Middle Initial……..Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Note: All parties signing the consent section must date their own signature. 


LSALT Peptide (AB001) 
Arch Biopartners 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample Consent Forms 
 
Confidential 
Page 4 of 5 
Final 1.0 
Participant Information and Consent Form - Part 2 SAD Version 2.0 dated 04-JUN-2019 


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Page 1 of 21 
 
Participant Information and Consent Form 
Part 2- Single Ascending Dose (SAD) Cohort 
 
Alfred Project Number: 
64/19 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and 
pharmacokinetic profile of LSALT peptide in healthy participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc  
Local Sponsor: 
Arch Clinical Pty Ltd  
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 
PART 1 - What does my participation involve? 
 
1. 
Introduction 
You are invited to take part in this research study because you are a healthy male/female aged 18-
55 years old who potentially meets the study participation requirements.  
This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in 
your blood) of a single/multiple intravenous (IV) infusion (into the vein) doses of a new drug called 
LSALT.  
This Participant Information and Consent Form (PICF) tells you about the research study. It also 
explains the tests and treatments that will be completed during study participation. This information 
is given to you to help you decide if you want to take part in this research study. Please read this 
information carefully and ask the study doctor questions  about anything that you don’t understand 
or want to know more about before deciding whether or not you want to take part. If you wish to do 
so, please take the time to talk about it with a relative, friend or your local doctor before deciding 
to participate. 
Once you understand what the study is about and if you agree to take part in it, you will be asked 
to sign a Consent Form. By signing the Consent Form, you indicate that you understand the 
information and that you give your consent to participate in the research study.  
Your information regarding participation in the study will be provided to your usual doctor if you opt 
to provide their contact details to study staff. 
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. 


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Page 2 of 21 
If you decide you want to take part in the research study, you will be asked to sign the consent 
section. By signing it you are telling us that you: 
• 
understand the information you have read; 
• 
consent to take part in the research study; 
• 
consent to follow the study requirements 
• 
consent to have the tests and treatments that are described; 
• 
consent to follow the study requirements and to keep follow-up appointments that are 
described; 
• 
consent to the use of your personal and health information as described. 
 
A description of this clinical trial is available on www.clinicaltrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results after 
the trial is completed. You can search this website at any time. 
 
You will be given a signed copy of the Participant Information and Consent Form to keep. 
 
2. 
What is the purpose of this research? 
Arch Biopartners Inc is developing the study drug LSALT peptide as a potential new treatment for 
acute kidney injury. Acute kidney injury is a common disease in people who are hospitalized or 
undergoing major surgery. Acute kidney injury is a serious complication that increases the risk of 
death and other serious health problems. Thus preventing acute kidney injury is desirable and may 
improve the health of people at risk of this complication. Currently, there are no specific treatments 
to prevent acute kidney injury. The LSALT peptide is a drug that is being developed to prevent 
acute kidney injury in people. LSALT works to prevent immune cells entering damaged parts of the 
body such as the kidneys. Preventing immune cells entering these parts of the body could 
potentially reduce the amount of damage from insults such as blockage of the blood supply.  In 
animal studies, the LSALT peptide has been shown to be very effective in protecting the kidney. In 
order to start treating kidney disease with the LSALT peptide in humans, researchers must first 
understand the safety profile of the drug and what happens to the drug once it is injected. 
The purpose of this research is to determine the safety and behaviour of LSALT peptide  in people. 
If the LSALT peptide is found to be safe, this will lead to future clinical trials testing the effectiveness 
of the drug in preventing acute kidney injury in people. This research will also lead to the design of 
new and improved versions of the LSALT peptide 
Medications, drugs and devices must be approved for use by the Australian Federal Government; 
the Therapeutic Goods Administration (TGA). LSALT peptide has not been approved for marketing 
by the TGA in Australia (and is not yet approved anywhere else in the world). Therefore, the use 
of LSALT peptide in this study is experimental. 
LSALT peptide has been tested in animals and found to be safe at doses much higher than planned 
in this study. LSALT peptide has never been tested in humans. Although unlikely, there is a risk 
of death in first in human studies such as this study. 
In other studies, some unexpected serious, life-threatening side effects have occurred following 
the administration of new experimental treatments. It is unknown, however unlikely, whether some 
unexpected serious, life threatening side effects could occur with LSALT peptide. You will be 
monitored closely for them and treated if they occur.  
This study is being conducted at the Centre for Clinical Studies at Nucleus Network Pty. Ltd., 
Melbourne, Australia. The Clinical Research Organisation involved in monitoring the study is 
Syneos Health.Arch Biopartners Inc is the international company sponsoring this study, along with 
Arch Clinical Pty Ltd, the Australain company    


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3. 
What does participation in this research involve? 
Before you begin the study, you will be given detailed information about LSALT peptide, the study, 
and any other relevant information by research staff. You are encouraged to ask questions until 
you are sure that you fully understand the nature of and requirements of the study. 
If you decide to be assessed for inclusion in the study, you will be asked to visit the Centre for 
Clinical Studies for an initial assessment visit (screening visit). Before any procedures are 
undertaken, you will be asked to sign a consent form. You will then have some tests to check that 
the study is suitable for you. The screening visit may take between 1 and 2 hours. 
 
This study will enrol approximately 52 participants into 3 parts; 
• 
Part 1- Low dose Cohort- 4 participants will be dosed with a low dose of the study drug 
(0.01mg, 0.1mg, 0.3mg and 0.5mg), 1 dose of increasing strength for each participant. 
Participants will be dosed on Day 1 with a single dose of the study drug and will stay in the 
unit for an inpatient stay of 2 days. You are then required to return for a single follow up 
visit. 
• 
Part 2- Single Ascending dose Cohort- 24 participants will be split into 3 cohorts (groups) 
of 8 and will be dosed with a single dose of the study drug (1mg, 2.5mg and 5mg) during 
an inpatient stay of 2 days. You are then required to return for 2 separate follow up visits 
• 
Part 3- Multiple Ascending dose Cohort- 16 participants will be split in 2 cohorts (groups) 
of 8. Participants will be dosed with the study drug once or twice per day for 3 days with 
an inpatient stay of 4 nights. You are then required to return for 3 separate follow up visits. 
This PICF will only outline the requirements of Part 2 (Single Ascending Dose) cohort of the 
study.  
This study will enrol approximately 24 participants into 3 groups (or cohorts) with 8 participants in 
each cohort.  
There will be 2 participants from each cohort that will be given the study drug or placebo at least 
24 hours before the rest of the participants; one will get the active drug and the other one will get 
the placebo. These 2 participants are called “sentinels”. You will be told if you are assigned to the 
sentinel group. 
The study is placebo controlled, meaning that some participants will receive a dose containing 
active study drug and some will receive a dose containing placebo drug. The dose containing the 
placebo will look the same as the dose containing active study drug but will not contain any active 
ingredients in it. You will not have a choice as to whether you receive the active study drug or the 
placebo (you will be assigned randomly, like flipping a coin). Neither you nor the study staff will 
know if you are assigned to receive the active study drug or the placebo, although in an emergency, 
the study staff can find out. 
As this is a dose escalation study, the first group enrolled will receive the lowest dose and once it 
is considered to be safe, the next group will be enrolled who will receive the next higher dose. Dose 
escalation will only proceed following review of all available safety data by the Principal Investigator 
in consultation with the sponsor and there is confirmation that it is safe to continue with the next 
higher dose strength in the next group. The study can be stopped at any time, based on evaluation 
of the side effects of the study medication. 
The dose levels planned for this study range from 1.0 to 5 milligrams. You will be informed of the 
exact dose for your cohort when you check in to the clinical unit. 
The table on the next page explains the planned doses for this study: 


Study Drug- LSALT peptide 
 
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Study sequence: 
Your total participation in the study will consist of approximately 6 weeks as follows;  
• 
Screening visit: will occur within 29 days of your dose. You will undergo assessments to 
determine if you are eligible for the study 
• 
Admission and treatment period: you will be required to attend the study centre for a 2 
night in patient stay  
• 
Follow up period: you will be required to return to the study centre for 2 follow up visits 
Below is a picture outlining the study schedule for the study: 
 
If you decide to be assessed for inclusion into the study, you will be asked to visit the Centre for 
Clinical Studies for the screening visit. The  screening visit may take between 1 and 2 hours.  
 
Screening visit (between Day -29 to Day -2) 
After reading this information sheet and if you agree to participate in the study, you will be asked 
to sign the attached consent form. The study doctor will perform a medical examination to ensure 
that it is appropriate for you to be part of the study. You will undergo the following assessments: 
• 
You will be asked about your current health status and about your medical history, 
including all medications, over-the-counter and herbal medications that you have been, and 
are currently taking. 
• 
You will be asked some personal details about yourself, including your date of birth. 
• 
You will be asked about your alcohol history and you will undergo an alcohol breath test.  
• 
You will be asked to provide a urine sample to assess your general healthy and to test for 
medications of addiction as listed below: 
- 
to test for nicotinine level (to test if you have smoked cigarettes) 
o to test for drugs of addiction (such as Methamphetamine, Cocaine, Cannabinoids, 
Opiates, 
Phencyclidine, 
Barbiturates, 
Benzodiazepines, 
Methadone, 
and 
Amphetamine). This is a study requirement and the results will remain confidential. 
The tests may reveal that you have previously used illegal medications. That 
information will be stored in a re-identified (or coded) format. If the Centre for Clinical 
Studies is required to disclose that information, it may be used against you in legal 
proceedings or otherwise. If you test positive for any of these substances, you will 
be excluded from further participation in this study. 
Screening: 
within 29 days
Admit: Day -1
Dose: Day 1
Discharge: Day 2
Follow up
Day 4, 7
Cohort 
Dose 
1 
 Single dose 1.0 mg 
2 
Single dose 2.5 mg 
3 
Single dose 5 mg 


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• 
Your vital signs such as blood pressure, pulse rate and oral body temperature will be 
measured.  
• 
You will have a full physical examination (PE), your height and weight will be measured 
to determine your body mass index (BMI). 
• 
You will have electrocardiograms (ECG) (recording of your heart’s electrical activity and 
rhythm).   
• 
Blood sample (approximately 25mL / 5 teaspoons) will be collected for general safety 
assessemnts and to screen for HIV (AIDS virus), and hepatitis B and C. This is because 
the study doctors need to know about your general health and the health of your immune 
system. You will have to be fasting 8 hours for screening blood collection. 
o You will receive information and counselling before the HIV and hepatitis tests. If a 
test shows you have HIV or hepatitis you will not be included in this study, but you 
will have follow-up counselling and medical advice. If your test results are positive, 
the researchers are required by law to notify the Victorian government. Signing the 
consent form means you agree to have this testing. It will not be done without your 
consent. 
• 
Pregnancy Test: from your blood sample, a pregnancy test will be performed.  
• 
Chest x-ray: you will have a chest x-ray at a local clinic since the LSALT peptide could 
affect your lungs. You will be provided with details about where to go for this assessment 
when appropriate.  
If for any reason, the trial is found to not be suitable for you, staff from the Centre for Clinical Studies 
will contact you and provide follow-up treatment advice where applicable. 
Treatment and Follow-up Period 
If you are eligible to enter the study, you will be admitted to the clinical unit the day before the 
planned dosing day. You will undergo a number of procedures to confirm your suitability for 
participation in the trial (see table below). 
You will be required to stay in the clinical unit for 2 consecutive nights and discharged home on 
Day 2. 
To ensure sufficient number of participants are available for dosing, additional volunteers called 
‘alternates’ will be recruited and admitted to the clinical unit. If you are an alternate, you may be 
asked to participate in the study if someone is not included in the dosing group. You will be informed 
if you are an alternate  before treatment is given. 
The study drug will be administered as an IV infusion over a period of approximately 2 hours, or as 
determined by the PI and the safety monitoring committee.    
On the morning following your first day in the clinical unit, a cannula will be inserted into a vein in 
your arm. This is a small, flexible tube which will allow blood to be collected easily throughout your 
unit stay and prevents the need for repeated needles to be inserted in your vein to collect each 
sample. The location of the cannula may need to be repositioned if required. 
During the occasions that you are required to stay overnight, you will be provided meals. You will 
need to have fasted from all food and drink except water for at least 8 hours before providing blood 
samples. 
You will undergo the following procedures at various time points during the study, the table of 
assessments below outlines when these events will take place:  
 
• 
Vital signs: Oral temperature, pulse rate and blood pressure will be measured. 
• 
12-Lead Electrocardiogram (ECG): will be performed to assess your heart rhythm. 
• 
Physical Examination: will be performed to assess your general health. This will include 
measuring your body weight. 


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• 
Safety blood and urine samples: approximately 25 ml (approx. 4 teaspoons) of blood and 
a urine sample will be collected to assess your general health. When you check in, the urine 
sample will also be collected to test for drugs of addiction and to test if you have smoked. 
A positive test will exclude you from further participation in the trial. A pregnancy test will 
also be performed from your urine sample a number of times during the study.  
• 
Alcohol breath test: You will undergo an alcohol breath test when you check into the 
clinical unit to see if you have been drinking any alcohol in the past 24 hours. A positive 
test will exclude you from further participation in the trial. 
• 
Study drug administration: The study drug will be administered as an IV infusion over 
approximately 2 hours.  
• 
Pharmacokinetic (PK) samples: will be collected to measure the amount of LSALT 
peptide in your blood, the break down products and to assess the effect it has on your body. 
Approximately 5 mL of blood (approx. 1 teaspoon) will be collected at various time points 
during a study visit.  
• 
Concomitant Medication review: you will be asked if you have recently taken any 
medications.  
• 
Adverse Events: You will be asked about how you are feeling (whether you feel alright, 
different from normal or unwell) at regular intervals, please tell a study team member if you 
have any changes in your health or concerns. 
You will be discharged from the clinical unit once all study procedures are complete and the clinical 
staff sees no changes in your health which would prevent your discharge from the clinical unit.  
 
Follow up visits 
Following discharge on Day 2, you will be required to attend the Centre for Clinical Studies on two 
separate occasions, Day 4, and 7.  
  
The study doctor will ask you to return to the research unit on these days and may ask you to return 
after this period, if he feels it is necessary. In the event it is necessary to further evaluate the safety 
or effects of the medication, it may be necessary to have access to additional information about 
your health status. Your study doctor may attempt to obtain study-related information about your 
health from you or from other sources, including your primary care physician. This may include 
contacting you again by phone or letter. 
 


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The table below outlines the assessments that will be performed during Part 2 (Single Ascending Dose) cohort of the study: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Key; LFT= liver function tests. PK= pharmacokinetic, INR/PTT=blood clotting ability, B-hCG= pregnancy test  
 
Study Day 
Screen 
-29 to -2 
-1 
1 
2 
4 
7 
In patient period 
 
X 
X 
 
 
 
Informed consent 
X 
 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
Physical Exam 
X 
X 
 
X 
X 
X 
Alcohol Breath Test/drug screen 
X 
X 
 
 
 
 
Urinalysis 
X 
X 
 
 
 
X 
Complete blood count (CBC)  
X 
X 
 
X 
 
X 
Chemistry 
X 
X 
 
X 
 
X 
Creatine/eGFR 
X 
X 
 
X 
 
X 
LFTs- Liver function test (blood sample) 
X 
X 
 
X 
 
X 
PK 
 
 
X 
X 
X 
X 
INR/PTT blood sample for ( blood clotting ability) 
X 
 
 
X 
 
 
Chest X-ray 
X 
 
 
 
 
X 
Electrocardiogram ECG 
X 
X 
X 
X 
X 
X 
B-hCG blood sample for pregnancy test 
X 
X 
 
 
 
X 
Adverse Event 
X 
X 
X 
X 
X 
X 
LSALT Administration 
 
 
X 
 
 
 
Discharge from unit 
 
 
 
X 
 
 
Follow up 
 
 
 
 
X 
X 


 
 
 
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4. 
What do I have to do? 
It is important for your own safety that you inform the study doctor or staff of your complete 
medical history and all medications, supplements, and/or herbal preparations that you have 
taken within the past 6 months or are currently taking. If you have any health problems, please 
notify your study doctor immediately. As mentioned earlier in this document, if you notice any 
changes in your health or have concerns during your participation in the study, also inform 
your study doctor or study staff as soon as possible. So long as you continue to participate, 
you should take the study drug as directed. You must always follow the instructions of the 
study doctor and staff. 
Please note that in the days leading up to your admission to the clinical unit, there are a few 
things you must avoid to be included in the study:  
• 
You should not have participated in other clinical trials within 1 month before signing 
this consent form. 
• 
You should not have donated blood within 60 days before admission into the unit.  
• 
You will be asked to come to the Centre for Clinical Studies in fasting condition (no 
consumption of any food or drinks, with the exception of water, during the 8 hours prior 
to arrival), at admission to the clinical unit and at the follow-up visit. During your stay 
in the clinical unit, you should follow the instructions of the study staff concerning your 
intake of food and beverages 
• 
Please do not take any prescription medication for 2 weeks prior to your admission to 
the clinical unit.  
• 
Please do not take any over the counter medication for 7 days prior to admission. 
Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day 
respectively) are acceptable. Routine vitamins and supplements are permissible at the 
discretion of the investigator. Please ask if you have any questions.  
• 
Social and light smokers (up to 10 cigarettes per day) are allowed to enter the study, 
however they must agree and be able to abstain from smoking for the full inpatient 
period.  
• 
Please do not consume any caffeine, quinine (tonic water) and xanthine containing 
beverages (tea, coffee, cola, chocolate) for 48 hours prior to your screening 
appointment and 48 hours prior to your admission to the clinical unit. Consumption of 
quinine, caffeine and xanthine containing beverages is not allowed throughout the 
clinical stay. Please ask your study doctor if you have any questions regarding the 
above restrictions.  
• 
Please do not consume alcohol for 48 hours prior to your admission to the clinical unit 
until after your final visit.  
• 
Please do not perform any strenuous exercise for 2 days prior to your admission to the 
clinical unit and until after your final visit. 
• 
You should not have donated blood in the 2 months prior to starting the study and 
should refrain from donating blood during the study and within 2 months after your final 
visit. If you donate blood after this period, you must inform donor centre staff that you 
have recently been involved in a clinical study.  
Please note that you will not be allowed to smoke while at the study centre. 
In case of emergency, you must be easily contactable by phone and/or email. You will be 
given a Participant Wallet Card which contains emergency contact information and information 
about your study commitments. You must carry the Participant Wallet Card with you at all 
times until the end of the study. 


 
 
 
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5. 
Other relevant information about the research study 
This study is being conducted at the Centre for Clinical Studies in Australia. There are no 
researchers from other organisations working in collaboration. 
A representative of Arch Biopartners Inc (study sponsor) may be present for inspections in the 
unit during the study.  
 
6. 
Do I have to take part in this research study? 
Participation in any research study is voluntary. If you do not wish to take part, you don’t have 
to. If you decide to take part and later change your mind, you are free to withdraw from the 
study at any time without providing any reason. Your study doctor may ask you the reason for 
your withdrawal, you can answer or not.  
Your decision whether to take part or not, or to take part and then withdraw, will not affect your 
relationship with the Centre for Clinical Studies and will not involve any penalty or loss of 
benefits to which you would be otherwise entitled. Should you withdraw from the study before 
the final visit you may receive a partial payment according to the number of visits you have 
attended. 
Before you make your decision, a member of the research team will be available so that you 
can ask any questions you have about the research study. You can ask for any information 
you want. Sign the Consent Form only if you agree to participate and only after you have had 
a chance to ask your questions and have received satisfactory answers. 
 
7. 
What are the alternatives to participation? 
Since this study is intended only to evaluate the safety, tolerability and pharmacokinetics of 
LSALT peptide, your alternative to be a volunteer in this study is to choose not to participate 
in the study. 
 
8. 
What are the possible benefits of taking part? 
If you agree to take part in this study, there will be no direct benefit to you. However, your 
participation in this study may help develop important scientific knowledge that could 
contribute to the development of this medication for kidney diseases. We hope the information 
learned from this study will benefit others in the future. 
 
9. 
What are the possible risks and disadvantages of taking part? 
LSALT peptide is an experimental medication, therefore the risks to human participants have 
not been fully evaluated. 
Medical treatments often cause side effects. You may have none, some or all of the effects 
listed below, and they may be mild, moderate or severe. If you have any of these side effects, 
or are worried about them, talk with a study doctor. Your doctor and study staff will also be 
watching you closely for side effects. 
Many side effects go away shortly after treatment ends. However, sometimes side effects can 
be serious, long lasting or permanent. If a severe side effect or reaction occurs, your doctor 
may need to stop your treatment. Tell your study doctor or site staff if you notice any changes 
in your health or have concerns.  Your study doctor will discuss the best way of managing any 
side effects with you. 


 
 
 
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There may also be side effects that are not expected or are not known that may be serious. 
Tell your doctor immediately about any new or unusual symptoms or changes in your health 
that you become aware of. The treatment of the side effects will depend on the type and 
severity of the symptom(s). 
If during screening or participation in this research study a previously unknown medical 
condition is discovered the study doctor will discuss: 
• 
whether you are eligible for study participation  
• 
if you require referral to your usual physician or to a specialist 
 
Risks of Study Drug: 
Currently, the risks of LSALT peptide in humans are unknown. There may be side effects 
related to the infusion of the drug such as lightheadedness, nausea or an allergic reaction. In 
animals, these infusion related side effects were easily treated with anti-histamines. However, 
the drug will be given at much lower doses than the amount administered to animals, and will 
be infused very slowly to minimize these side effects.There is also a small risk that you may 
develop antibodies against the the LSALT peptide which may cause some medical problems, 
especially if you were to receive the drug again in the future. 
 
Blood Draw/ Cannula Insertion Risks: 
You may have pain or bruising at the site where blood is drawn or a cannula (a temporary 
small plastic tube) is inserted. An infection at the site of blood draws or cannula insertion is 
also possible. The insertion of the cannula (small plastic tube) or the drawing of blood may be 
associated with some pain. Possible side effects from blood drawing include faintness, 
inflammation of the vein, pain, bruising or bleeding at the site of puncture. These will normally 
disappear a few days after the procedure.  
 
Blood Pressure Measurement Risks: 
There is no risk to your health when having your blood pressure tested. You may experience 
some feeling on discomfort as the cuff inflates and squeezes your arm, but it should only last 
a few seconds. Sometimes, there are tiny red spots that appear after the test just below the 
location of the cuff, they should be painless.  
 
Electrocardiogram (ECG) risks: 
The ECG test is a recording of the electrical activity of your heart. The sticky pads used may 
be cold when applied and sometimes cause some discomfort such as redness or itching. If 
there is hair in the area where patches need to be applied, this area will be shaved in order to 
complete the ECG. Shaving may result in irritation. 
 
Risks of Chest X-ray (Radiation Risk) 
This research study involves exposure to a very small amount of radiation. As part of everyday 
living, everyone is exposed to naturally occurring background radiation and receives a dose 
of about 2 millisieverts (mSv) each year. The effective dose from this study is about 0.04 mSv. 
At this dose level, no harmful effects of radiation have been demonstrated as any effect is too 
small to measure. The risk is believed to be minimal.  
Have you been involved in any other research studies that involve radiation? If so, please tell 
us. Please keep information contained within the Patient Information and Consent Form about 
your exposure to radiation in this study, including the radiation dose, for at least five years. 


 
 
 
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You will be required to provide this information to researchers of any future research projects 
involving exposure to radiation. 
Allergic Reaction Risks: 
There is a risk of allergic reaction. If you have a very serious allergic reaction, you may be at 
risk of death.  
Symptoms may include difficulty in breathing, dizziness, itching, swelling of the lips, tongue or 
throat, coughing, rash. 
In general, most symptoms are manageable. They are mild to moderate in severity. But life-
threatening reactions may occur at any drug dose. If you believe you are having a serious 
allergic reaction, you should seek emergency medical assistance immediately. 
Please notify the study doctor immediately if you experience any of these symptoms. Some 
symptoms of allergic reactions are: 
• 
Rash 
• 
Wheezing and difficulty breathing 
• 
Dizziness and fainting 
• 
Swelling around the mouth, throat or eyes 
• 
Fast pulse 
• 
Sweating 
You will be monitored very carefully for any signs or symptoms that you may be having an 
allergic reaction and appropriate care will be taken by the study doctor and nursing staff.  
If you do not understand what some of these side effects or risks mean, ask the study doctor 
or the study staff to explain them to you. 
Pregnancy Risk:  
The risks of the study drug to an unborn child or nursing infant are unknown and may be 
hazardous. It is important that you use the appropriate forms of birth control as described 
below:  
If you are male, you must be either vasectomised, sexually abstinent (when this is in line with 
your preferred and usual lifestyle) or agree to use a condom. If you use a condom and your 
partner is of childbearing potential, she must use another method of contraception resulting in 
a highly effective method of birth control for the full duration of the study and for 3 months after 
the last dose of study drug. 
 
If you are female and of childbearing potential, you must also use a double barrier method of 
contraception for at least 90 days after the last dose of study drug.  
 
Double barrier contraception is defined as a condom AND one of the following; 
• 
Birth control pills (The Pill) 
• 
Birth Control Patch (e.g. Ortho Evra) 
• 
NuvaRing® 
• 
Depot or injectable birth control 
• 
IUD (Intra Uterine Device) 
• 
Documented evidence of surgical sterilization at least 6 months prior to screening 
visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. 
 
Please ask you study doctor if you have any questions regarding the forms of birth 
control that must be used while participating in this study. 
If you are male, you must not donate sperm for at least 90 days after last dose of study drug. 


 
 
 
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If you/your partner becomes pregnant during the study or up to 90 days after the last dose of 
study drug, please tell your study doctor or staff immediately as we would like to request 
permission to follow this pregnancy and its outcome. The study doctor will also report the 
pregnancy to the Human Research Ethics Committee and to the study Sponsor.  
Allowing the pregnancy and outcome to be followed is optional. If your partner agrees to have 
this pregnancy followed, then she will be asked to sign a separate Pregnancy Follow-Up 
Participant Information and Consent Form. The information collected is similar to that which 
would be routinely collected during a typical pregnancy consultation. The consultation will be 
done in person at the Centre for Clinical Studies, and/or by telephone.  
In addition, she will be asked to notify the study doctor about the outcome of the pregnancy. 
If she forgets, she will be contacted to obtain this information. This outcome data collected 
includes: pregnancy complications and outcome, birth weight, birth defects (if any), and 
additional factors that may have had an impact on the outcome of the pregnancy (drugs, 
infections, family history etc.).  
The study doctor may also need to contact the gynecologist of your partner. 
 
10. 
What will happen to my test samples? 
By consenting to take part in this study, you also consent to the collection and testing of your 
urine and blood samples for this research. The total volume of blood taken for the entire study 
is approximately 170ml (approx. 1/2 cup). For comparison, a standard blood donation is 
approximately 470mL (approx. 2 cups). Additional blood samples may also be collected for 
safety reasons.  
The blood and urine samples collected for the assessment of your health status (e.g. liver and 
kidney function tests) will be processed by a local pathology laboratory. These samples will 
be labelled with your unique study participant number, your initials and date of birth, and will 
not contain any information that can identify you personally. These samples will be destroyed 
following analysis. 
This research project involves the collection of information about your use of drugs and 
alcohol. Participation in the research project includes blood and urine analysis to determine 
the presence of drugs such as amphetamines, methamphetamines, benzodiazepines, 
barbiturates, marijuana, cocaine, PCP, methadone, opioids (narcotics). The test may reveal 
that you have previously used illegal drugs. That information will be stored in a re-identifiable 
(or coded) format. This is a study requirement and the results will remain confidential. In the 
event that the Centre for Clinical Studies is required to disclose that information, it may be 
used against you in legal proceedings or otherwise. If you test positive for any drugs of 
addiction, you will not be able to participate in this study. 
You will receive information and counselling before the HIV and hepatitis tests. If a test shows 
you have HIV or hepatitis you will not be included in this study, but you will have follow-up 
counselling and medical advice. If your test results are positive, the researchers are required 
by law to notify the Victorian government. Signing the consent form means you agree to have 
this testing. It will not be done without your consent. 
Blood samples taken for pharmacokinetics will be sent to various Sponsor-approved 
laboratories in Canada. These samples will be labelled with your unique study participant 
number and will not contain any information that can identify you personally. These samples 
will be stored during the study at a secure premise and the samples will be destroyed following 
analysis at the end of the study. 
 


 
 
 
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11. 
What if new information arises during this research study? 
Sometimes during the course of a research study, new information becomes available about 
the treatment that is being studied. If this happens, your study doctor will tell you about it and 
discuss with you whether you want to continue in the research study. If you decide to withdraw, 
your study doctor will make arrangements for your regular health care to continue. If you 
decide to continue in the research study you will be asked to sign an updated consent form. 
Also, on receiving new information, your study doctor might consider it to be in your best 
interests to withdraw you from the research study. If this happens, he/she will explain the 
reasons and arrange for your regular health care to continue. 
 
12. 
Can I have other treatments during this research study? 
Whilst you are participating in this research study, you are not able to take any medications or 
treatments other than those agreed upon at the start of your participation in the study. It is 
important to tell your study doctor and the study staff, at each clinic visit, about any treatments 
or medications you may have taken, including over-the-counter medications, vitamins or 
herbal remedies, acupuncture or other alternative treatments. 
 
13. 
What if I withdraw from this research study? 
If you decide to withdraw from the study, please notify your study doctor or staff before you 
withdraw. This notice will allow the study doctor to discuss any health risks or special 
requirements linked to withdrawing. 
If you do withdraw your consent during the research study, any information collected on you 
up to the point of withdrawal will be used. Data collected after your withdrawal, if any, may be 
used: 
• If you decide to withdraw from the study, any adverse event not resolved at this time 
will be followed until its resolution by your research doctor to ensure your medical 
follow-up. You may also contact your research doctor if you experience a new adverse 
event. 
• If you withdraw from the study for a reason other than your own decision, your 
research doctor may contact you to request any relevant information and / or 
documentation regarding your medical care. 
• If you withdraw your consent, all your biological sample(s) will be destroyed without 
disclosing your identity. If analysis is required for the study, it will be analysed before 
destroying your samples.   
 
14. 
Could this research be stopped unexpectedly? 
This research study may be stopped unexpectedly for the reasons listed below.   
• 
Unacceptable side effects 
• 
The drug being shown not to be safe 
• 
Decisions made in the commercial interests of the sponsor or by local regulatory/health 
authorities 
• 
If you don’t follow the instructions of the clinical unit staff; or 
• 
If the study doctor decides it is in the best interest of your health and welfare to stop. 
 


 
 
 
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Page 14 of 21 
15. 
What will happen when the research study ends? 
The study drug will not be available to you following completion of participation.  
The study data will be analysed, and a final report provided to the study doctor, who will share 
the results with you when requested. The disclosure and/or any published results will be 
available to you when requested. It is usual for a number of years to elapse before definitive 
results of this type of study are available. These may be published in medical journals that are 
available to the public. You should feel free to ask the study staff about this. 
 
Part 2 - How is this study being conducted? 
 
16. 
What will happen to information about me? 
Any information and data obtained/retained in connection with this research study that can 
identify you will remain confidential and will only be used for the purpose of this research study 
and future research related to the pathway being studied and related disease conditions. 
Information about you may be obtained from your health records held at other health services 
for the purpose of this research. By signing the consent form you agree to the study team, 
including Sponsor delegates, accessing health records if they are relevant to your participation 
in this research study to ensure data accuracy. Whilst every effort will be made to keep your 
personal information confidential, the data gathered for this study will also be reviewed by a 
Sponsor delegate. This delegate will have access to your medical records, without violating 
your confidentiality to the extent permitted by local laws and regulations,  to verify the data are 
correct and complete. 
The data collected as part of this research study may be reviewed by representatives of the 
international sponsor, Arch Biopartners Inc, its affiliated companies and/or subcontractors, the 
local sponsor, Arch Clinical Pty Ltd, the Research Ethics Committee of Alfred HREC, by 
authorised representatives of the Australian Therapeutic Goods Administration or other 
regulatory agencies. Information may be transferred to parties in countries (and regions) other 
than Australia including the US, and Europe for these purposes. Syneos Health, Arch 
Biopartners Inc representatives, collaborators and contracted agencies comply with internal 
procedures to protect personal information even in countries whose data privacy laws are less 
strict than those of this country. In all cases when dealing with your personal (coded) 
information. Arch Biopartners Inc, and any of their agents will comply with the Privacy Act 
1988. If you have any concerns on how your information is handled, please feel free to ask a 
member of the study team for more information. 
By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Study Medical Records 
Data from your study medical record will be identifiable and stored in secured offices at the 
Centre for Clinical Studies. Only research team members and authorised representatives from 
the Sponsor, the Ethics Committee or regulatory agencies will have access to your medical 
records. 
You have a right to access and request correction to your information. 
 
Case Report Form (CRF) 
Information you provide us will be recorded in electronic case report forms (CRF).  Your 
information will be coded by your unique study number, your gender and birth date only and 


 
 
 
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thus will be considered re-identifiable. The recorded data will be kept in an electronic database 
which will be managed throughout the study by Syneos Health who are monitoring the study. 
Information from these CRFs will form part of the study results, which may be published. A 
copy of the CRF entries and your deidentified study medical record will be kept indefinitely 
with all other study related documents. 
By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Publications 
A report of the study results may be submitted for publication. In any publication and/or 
presentation, information will be provided in such a way that you cannot be identified, except 
with your permission). 
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you 
have the right to request access to your information collected and stored by the research team. 
You also have the right to request that any information with which you disagree be corrected. 
Please contact the study team member named at the end of this document if you would like 
to access your information. 
If you want to know more about the Centre for Clinical Studies’ approach to privacy or access 
any of your information held by the Centre for Clinical Studies, you can contact Dr Ben Snyder  
at the Centre for Clinical Studies. 
It is desirable that your local doctor be advised of your decision to participate in this research 
study. By signing the consent section, you agree to your local doctor being notified of your 
decision to participate in this research study. 
Information about your participation in this research study may be recorded in your health 
records. 
 
17. 
Complaints and compensation 
If you suffer any injuries or complications because of this research study, you should contact 
the study doctor or study team as soon as possible and you will be assisted with arranging 
appropriate medical treatment. If you are eligible for Medicare, you can receive any medical 
treatment required to treat the injury or complication, free of charge, as a public patient in any 
Australian public hospital. 
There are two avenues that may be available to you for seeking compensation if you suffer an 
injury as a result of your participation in this research study: 
• 
The pharmaceutical industry has set up a compensation process, with which the local 
sponsor of this research study, Arch Biopartners Inc, has agreed to comply. Details of 
this process and conditions are set out in the Medicines Australia Guidelines for 
Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical 
Trial. In accordance with these Guidelines, the sponsor will determine whether to pay 
compensation to you, and if so, how much. The research staff will give you a copy of 
the Guidelines together with this Participant Information and Consent Form. If you have 
any questions about the Guidelines, please contact Dr Ben Snyder on 03 8593 9800. 
• 
You may be able to seek compensation through the courts. 
 
If you are not satisfied with how your personal information has been handled (as laid out in 
the Privacy Act, 1988), then you can make a complaint to the Office of the Australian 
Information Commissioner (OAIC). It is free to lodge a complaint and you do not need a lawyer, 


 
 
 
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however if you do decide to hire a lawyer, you must pay for the lawyer yourself. You can 
choose 
to 
withdraw 
your 
complaint 
at 
any 
time. 
Please 
refer 
to 
http://www.oaic.gov.au/privacy/privacy-complaints for more information. 
 
18 
Who is organising and funding the research? 
This research is being conducted by Arch Biopartners Inc based in Canada and in Australia 
by Arch Clinical Pty Ltd. The Clinical Research Organisation monitoring the study is Syneos 
Health.  Arch Biopartners Inc may benefit financially from this research study if, for example, 
the study assists to obtain approval for a new drug. 
By taking part in this research study you agree that samples of your blood (or data generated 
from analysis of these materials) may be provided to Arch Biopartners Inc. 
Arch Biopartners Inc may directly or indirectly benefit financially from your samples or from 
knowledge acquired through analysis of your samples. 
If knowledge acquired through this research leads to discoveries that are of commercial value 
to Arch Biopartners Inc, the study doctors or their institutions, there will be no financial benefit 
to you or your family from these discoveries. 
Arch Biopartners Inc, other researchers, or research companies may patent or sell discoveries 
that result from this research. Neither Arch Biopartners Inc nor the study doctor will compensate 
you if this happens. 
Contractors engaged by Arch Biopartners Inc will receive a payment from Arch Biopartners 
Inc for undertaking this research study. 
No member of the research team will receive a personal financial benefit from your 
involvement in this research study (other than their ordinary wages). 
 
19. 
Will I be reimbursed to take part in this research study? 
If you are eligible to enter the study, you will be reimbursed $75.00 for the screening and 
follow-up visits, and at an hourly rate of $12.50 per hour for the in-clinic stay part of this study. 
The total payment for participants who complete the entire study will be $975.00.  
Regardless of whether you withdraw early or complete the study, you will be reimbursed within 
10 business days of the end of study visit via electronic funds transfer directly into your bank 
account. Should you withdraw from the study before the final visit you will receive a partial 
payment according to the number of visits you have attended.  
Reimbursement compensates for your time, travel expenses, parking and inconvenience. This 
reimbursement is not made for undergoing risk nor is it to compensate you for any loss of 
earnings as a result of your participation. 
It is not anticipated that participation in this research study will result in any additional cost to 
you. 
 
20. 
Who has reviewed the research study? 
All research in Australia involving humans is reviewed by an independent group of people 
called a Human Research Ethics Committee (HREC) who make sure that the rights, safety 
and well-being of participants in a study are protected. The ethical aspects of this research 
study have been approved by The Alfred Ethics Committee. 
This study will be carried out according to the National Statement on Ethical Conduct in Human 
Research (March 2007) produced by the National Health and Medical Research Council of 


 
 
 
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Australia. This statement has 
been developed to protect 
the interests of people who 
agree to participate in human 
research studies. 
 
21. 
Further information and who to contact 
The person you may need to contact will depend on the nature of your query. 
If you want any further information concerning this study or if you have any medical problems 
which may be related to your involvement in the study (for example, any side effects), you can 
contact the principal study doctor (Dr Ben Snyder) on 03 8593 9800 or any of the following: 
General Enquiries:  
1800 243 733 
After hours contact (Centre for Clinical Studies) 24 hours 7 days a week 
On-call mobile:  
0429 353 069 
 
For matters relating to research at the site at which you are participating, the details of the 
local site complaints person are: 
Complaints contact person 
Position 
Complaints 
Email 
complaintsofficer@nucleusnetwork.com.au  
Privacy contact person 
Position 
Privacy Officer 
Email 
privacyofficer@nucleusnetwork.com.au  
 
If you have any complaints about any aspect of the study, the way it is being conducted or 
any questions about being a research participant in general, then you may contact: 
Reviewing HREC approving this research and HREC Executive Officer details 
Please reference the following Alfred Project number:  64/19 
 
 
 
Reviewing HREC name 
Alfred Hospital Ethics Committee 
Position 
Governance Officer,  
Ethics and Research Governance, Alfred Health 
Telephone 
(03) 9076 3619  
Email 
research@alfred.org.au  


 
 
 
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CONSENT 
Alfred Project Number: 
64/19 
Full Study Title: 
 A phase I double-blind, placebo-controlled, randomized, single 
and multiple ascending dose finding study to evaluate the safety 
and pharmacokinetic profile of LSALT peptide in healthy 
participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 I am 18 years of age or over 
 I have read the Participant Information Sheet, or someone has read it to me in a 
language that I understand. 
 I understand that my involvement in this study may not be of any direct benefit to me. 
 I have had an opportunity to ask questions and I am satisfied with the answers I have 
received. I have been given the name of a person to contact if I have any questions 
during the study. 
 I have been told that no information regarding my medical history will be divulged to 
unauthorised third parties and the results of any tests involving me will not be published 
to reveal my identity. 
 I understand the purposes, procedures and risks of the research described for this 
study. 
 I give permission for my doctors, other health professionals, hospitals or laboratories 
outside this hospital to release information to the Centre for Clinical Studies for the 
purposes of this study. I understand that such information will remain confidential.  
 I freely agree to participate in this research study as described and understand that I 
am free to withdraw at any stage during the study without prejudice to future treatment. 
If I withdraw from the study, I agree that the information collected about me up to the 
point when I withdraw may continue to be processed.  
 I understand that I will be given a signed copy of this document to keep. 
 
 
 
 
 


 
 
 
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Participant’s Name (printed)  …………………….…Middle Initial..……Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
Witness (only if required) 
Name of Witness to 
Participants signature 
(printed)  …………………….…Middle Initial…..…Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
* Witness is not to be the investigator, a member of the study team or their delegate.  In the event that an 
interpreter is used, the interpreter may not act as a witness to the consent process.  Witness must be 18 years 
or older. 
Declaration by Study Doctor/Senior Researcher 
I have given a verbal explanation of the research study, its procedures and risks and I believe 
that the participant has understood that explanation. 
Study Doctor/Researcher’s 
Name (printed)  ……….………………Middle Initial……..Surname……….……....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
A senior member of the research team must provide the explanation of, and information 
concerning, the research study. 
Note: All parties signing the consent section must date their own signature. 
 
 
 
 
 
 
 


 
 
 
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FORM FOR WITHDRAWAL OF PARTICIPATION 
Alfred Project 
Number: 
64/19 
Protocol 
Number: 
AB001 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and 
pharmacokinetic profile of LSALT peptide in healthy participants 
Test Drug 
Code: 
LSALT peptide 
International 
Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal 
Investigator: 
Dr Ben Snyder 
Location: Centre for Clinical Studies 
 
Declaration by Participant 
I wish to withdraw from participation in the above research study and understand that such 
withdrawal will not affect my routine treatment, my relationship with those treating me or my 
relationship with the Centre for Clinical Studies. 
Participant’s Name (printed)  ……………………….Middle Initial…..…Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Study Doctor to include a description of the circumstances for withdrawal, if provided by the 
participant. 
 
 
 
Declaration by Study Doctor 
I have given a verbal explanation of the implications of withdrawal from the research study 
and I believe that the participant has understood that explanation. 
 


 
 
 
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Page 21 of 21 
Study Doctor/Researcher’s 
Name (printed)  ……………….………Middle Initial……..Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Note: All parties signing the consent section must date their own signature. 
 


LSALT Peptide (AB001) 
Arch Biopartners 
16.1.3 List of IECs or IRBs - Representative Written Information for Subject and Sample Consent Forms 
 
Confidential 
Page 5 of 5 
Final 1.0 
Participant Information and Consent Form - Part 3 MAD Version 2.0 dated 06-JUN-2019 


Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 1 of 21 
 
Participant Information and Consent Form 
Part 3- Multiple Ascending Dose (MAD) Cohort 
 
Alfred Project Number: 
64/19 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and 
pharmacokinetic profile of LSALT peptide in healthy participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc  
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 
PART 1 - What does my participation involve? 
 
1. 
Introduction 
You are invited to take part in this research study because you are a healthy male/female aged 18-
55 years old who potentially meets the study participation requirements.  
This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in 
your blood) of a single/multiple intravenous (IV) infusion (into the vein) doses of a new drug called 
LSALT.  
This Participant Information and Consent Form (PICF) tells you about the research study. It also 
explains the tests and treatments that will be completed during study participation. This information 
is given to you to help you decide if you want to take part in this research study. Please read this 
information carefully and ask the study doctor questions about anything that you don’t understand 
or want to know more about before deciding whether or not you want to take part. If you wish to do 
so, please take the time to talk about it with a relative, friend or your local doctor before deciding  
to participate. 
Once you understand what the study is about and if you agree to take part in it, you will be asked 
to sign a Consent Form .  By signing the Consent Form, you indicate that you understand the 
information and that you give your consent to participate in the research study.  
Your information regarding participation in the study will be provided to your usual doctor if you opt 
to provide their contact details to study staff. 
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. 


Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 2 of 21 
If you decide you want to take part in the research study, you will be asked to sign the consent 
section. By signing it you are telling us that you: 
• 
understand the information you have read; 
• 
consent to take part in the research study; 
• 
consent to follow the study requirements 
• 
consent to have the tests and treatments that are described; 
• 
consent to follow the study requirements and to keep follow-up appointments that are 
described; 
• 
consent to the use of your personal and health information as described. 
 
A description of this clinical trial is available on www.clinicaltrials.gov. This website will not include 
information that can identify you. At most, the website will include a summary of the results after 
the trial is completed. You can search this website at any time. 
You will be given a signed copy of the Participant Information and Consent Form to keep. 
 
2. 
What is the purpose of this research? 
Arch Biopartners Inc is developing the study drug LSALT peptide as a potential new treatment for 
acute kidney injury. Acute kidney injury is a common disease in people who are hospitalized or 
undergoing major surgery. Acute kidney injury is a serious complication that increases the risk of 
death and other serious health problems. Thus preventing acute kidney injury is desirable and may 
improve the health of people at risk of this complication. Currently, there are no specific treatments 
to prevent acute kidney injury. The LSALT peptide is a drug that is being developed to prevent 
acute kidney injury in people. LSALT works to prevent immune cells entering damaged parts of the 
body such as the kidneys. Preventing immune cells entering these parts of the body could 
potentially reduce the amount of damage from insults such as blockage of the blood supply. In 
animal studies, the LSALT peptide has been shown to be very effective in protecting the kidney. In 
order to start treating kidney disease with the LSALT peptide in humans, researchers must first 
understand the safety profile of the drug and what happens to the drug once it is injected. 
The purpose of this research is to determine the safety and behaviour of LSALT peptide  in people. 
If the LSALT peptide is found to be safe, this will lead to future clinical trials testing the effectiveness 
of the drug in preventing acute kidney injury in people. This research will also lead to the design of 
new and improved versions of the LSALT peptide 
Medications, drugs and devices must be approved for use by the Australian Federal Government; 
the Therapeutic Goods Administration (TGA). LSALT peptide has not been approved for marketing 
by the TGA in Australia (and is not yet approved anywhere else in the world). Therefore, the use 
of LSALT peptide in this study is experimental. 
LSALT peptide has been tested in animals and found to be safe at doses much higher than planned 
in this study. LSALT peptide has never been tested in humans. Although unlikely, there is a risk 
of death in first in human studies such as this study. 
In other studies, some unexpected serious, life-threatening side effects have occurred following 
the administration of new experimental treatments. It is unknown, however unlikely, whether some 
unexpected serious, life threatening side effects could occur with LSALT peptide. You will be 
monitored closely for them and treated if they occur.  
This study is being conducted at the Centre for Clinical Studies at Nucleus Network Pty. Ltd., 
Melbourne, Australia. The Clinical Research Organisation involved in monitoring the study is 
Syneos Health. Arch Biopartners Inc is the international company sponsoring the study, along with 
Arch Clinical Pty Ltd, the Australian company .   
 


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Page 3 of 21 
 
 
3. 
What does participation in this research involve? 
Before you begin the study, you will be given detailed information about LSALT peptide, the study, 
and any other relevant information by research staff. You are encouraged to ask questions until 
you are sure that you fully understand the nature of and requirements of the study. 
If you decide to be assessed for inclusion in the study, you will be asked to visit the Centre for 
Clinical Studies for an initial assessment visit (screening visit). Before any procedures are 
undertaken, you will be asked to sign a consent form. You will then have some tests to check that 
the study is suitable for you. The screening visit may take between 1 and 2 hours. 
This study will enrol approximately 52 participants into 3 parts; 
• 
Part 1- Low dose Cohort- 4 participants will be dosed with a low dose of the study drug 
(0.01mg, 0.1mg, 0.3mg and 0.5mg), 1 dose of increasing strength for each participant. 
Participants will be dosed on Day 1 with a single dose of the study drug and will stay in the 
unit for an inpatient stay of 2 days. You are then required to return for a single follow up 
visit. 
• 
Part 2- Single Ascending dose Cohort- 24 participants will be split into 3 cohorts (groups) 
of 8 and will be dosed with a single dose of the study drug (1mg, 2.5mg and 5mg) during 
an inpatient stay of 2 days. You are then required to return for 2 separate follow up visits 
• 
Part 3- Multiple Ascending dose Cohort- 16 participants will be split in 2 cohorts (groups) 
of 8. Participants will be dosed with the study drug once or twice per day for 3 days with 
an inpatient stay of 4 nights. You are then required to return for 3 separate follow up visits. 
This PICF will only outline the requirements of Part 3 of the study, the Multiple Ascending 
Dose cohort 
This study will enrol approximately 16 participants into 2 groups (or cohorts) with 8 participants in 
each cohort.  
There will be 2 participants from each cohort that will be given the study drug or placebo at least 
24 hours before the rest of the participants; one will get the active drug and the other one will get 
the placebo. These 2 participants are called “sentinels”. You will be told if you are assigned to the 
sentinel group. 
The study is placebo controlled, meaning that some participants will receive a dose containing 
active study drug and some will receive a dose containing placebo drug. The dose containing the 
placebo will look the same as the dose containing active study drug but will not contain any active 
ingredients in it. You will not have a choice as to whether you receive the active study drug or the 
placebo (you will be assigned randomly, like flipping a coin). Neither you nor the study staff will 
know if you are assigned to receive the active study drug or the placebo, although in an emergency, 
the study staff can find out. 
As this is a dose escalation study, the first group enrolled will receive the lowest dose and once it 
is considered to be safe, the next group will be enrolled who will receive the next higher dose. Dose 
escalation will only proceed following review of all available safety data by the Principal Investigator 
in consultation with the sponsor and there is confirmation that it is safe to continue with the next 
higher dose strength in the next group. The study can be stopped at any time, based on evaluation 
of the side effects of the study medication. 
The dose levels planned for the MAD cohort of the study will range from 1.0 to 10 milligrams, 
depending on the safety results reviewed from the previous part of the study where a safe dose 
will be decided. You will be informed of the exact dose for your cohort when you check in to the 
clinical unit (Day 1). 
Study sequence: 


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Page 4 of 21 
Your total participation in the study will consist of approximately 8 weeks as follows;  
• 
Screening visit: will occur within 29 days of your first dose. You will undergo assessments 
to determine if you are eligible for the study 
• 
Admission and treatment period: you will be required to attend the study centre for a 4 
night in patient stay  
• 
Follow up period: you will be required to return to the study centre for 3 follow up visits 
Below is a picture outlining the study schedule for the study: 
 
 
 
 
If you decide to be assessed for inclusion into the study, you will be asked to visit the Centre for 
Clinical Studies for the screening visits. The screening visit may take between 1 and 2 hours.  
 
Screening visit (between Day -29 to Day -2) 
After reading this information sheet and if you agree to participate in the study, you will be asked 
to sign the attached consent form. The study doctor will perform a medical examination to ensure 
that it is appropriate for you to be part of the study. You will undergo the following assessments: 
• 
You will be asked about your current health status and about your medical history, 
including all medications, over-the-counter and herbal medications that you have been, and 
are currently taking. 
• 
You will be asked some personal details about yourself, including your date of birth. 
• 
You will be asked about your alcohol history and you will undergo an alcohol breath test.  
• 
You will be asked to provide a urine sample to assess your general healthy and to test for 
medications of addiction as listed below: 
o to test for nicotinine level (to test if you have smoked cigarettes) 
o to test for drugs of addiction (such as Methamphetamine, Cocaine, Cannabinoids, 
Opiates, 
Phencyclidine, 
Barbiturates, 
Benzodiazepines, 
Methadone, 
and 
Amphetamine). This is a study requirement and the results will remain confidential. 
The tests may reveal that you have previously used illegal medications. That 
information will be stored in a re-identified (or coded) format. If the Centre for Clinical 
Studies is required to disclose that information, it may be used against you in legal 
proceedings or otherwise. If you test positive for any of these substances, you will 
be excluded from further participation in this study. 
• 
Your vital signs such as blood pressure, pulse rate and oral body temperature will be 
measured.  
• 
You will have a full physical examination (PE), your height and weight will be measured 
to determine your body mass index (BMI). 
• 
You will have electrocardiograms (ECG) (recording of your heart’s electrical activity and 
rhythm).   
• 
Blood sample (approximately 25mL / 5 teaspoons) will be collected for general safety 
assessemnts and to screen for HIV (AIDS virus), and hepatitis B and C. This is because 
the study doctors need to know about your general health and the health of your immune 
system. You will have to be fasting 8 hours for screening blood collection. 
Screening: 
within 29 days
Admit: Day -1
Dose: Day 1 to Day 3
Discharge: Day 4
Follow up
Day 7, 14, and 21


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AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 5 of 21 
o You will receive information and counselling before the HIV and hepatitis tests. If a 
test shows you have HIV or hepatitis you will not be included in this study, but you 
will have follow-up counselling and medical advice. If your test results are positive, 
the researchers are required by law to notify the Victorian government. Signing the 
consent form means you agree to have this testing. It will not be done without your 
consent. 
• 
Pregnancy Test: from your blood sample, a pregnancy test will be performed.  
• 
Chest x-ray: you will have a chest x-ray at a local clinic since the LSALT peptide could 
affect your lungs. You will be provided with details about where to go for this assessment 
when appropriate.  
If for any reason, the trial is found to not be suitable for you, staff from the Centre for Clinical Studies 
will contact you and provide follow-up treatment advice where applicable. 
 
Treatment and Follow-up Period 
If you are eligible to enter the study, you will be admitted to the clinical unit the day before the 
planned dosing day. You will undergo a number of procedures to confirm your suitability for 
participation in the trial (see table below). 
You will be required to stay in the clinical unit for 4 consecutive nights and discharged home on 
Day 4. You will receive the experimental drug on Days 1, 2 and 3. 
To ensure sufficient number of participants are available for dosing, additional volunteers called 
‘alternates’ will be recruited and admitted to the clinical unit. If you are an alternate, you may be 
asked to participate in the study if someone is not included in the dosing group. You will be informed 
if you are an alternate on Day 1 before treatment is given. 
The study drug will be administered as an IV infusion over a period of approximately 2 hours, or as 
determined by the PI and the safety monitoring committee.    
On the morning following your first day in the clinical unit, a cannula will be inserted into a vein in 
your arm. This is a small, flexible tube which will allow blood to be collected easily throughout your 
unit stay and prevents the need for repeated needles to be inserted in your vein to collect each 
sample. The location of the cannula may need to be repositioned if required. 
During the occasions that you are required to stay overnight, you will be provided meals. You will 
need to have fasted from all food and drink except water for at least 8 hours before providing blood 
samples. 
You will undergo the following procedures at various time points during the study, the table of 
assessments below outlines when these events will take place:  
 
• 
Vital signs: Oral temperature, pulse rate and blood pressure will be measured. 
• 
12-Lead Electrocardiogram (ECG): will be performed to assess your heart rhythm. 
• 
Physical Examination: will be performed to assess your general health. This will include 
measuring your body weight. 
• 
Safety blood and urine samples: approximately 25 ml (approx. 3 teaspoons) of blood and 
a urine sample will be collected to assess your general health. When you check in, the urine 
sample will also be collected to test for drugs of addiction and to test if you have smoked. 
A positive test will exclude you from further participation in the trial. A pregnancy test will 
also be performed from your urine sample a number of times during the study. 
• 
Alcohol breath test: You will undergo an alcohol breath test when you check into the 
clinical unit to see if you have been drinking any alcohol in the past 24 hours. A positive 
test will exclude you from further participation in the trial. 
• 
Study drug administration: The study drug will be administered as an IV infusion over 
approximately 2 hours on Days 1, 2 and 3. 


Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
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• 
Pharmacokinetic (PK) samples: will be collected to measure the amount of LSALT 
peptide in your blood, the break down products and to assess the effect it has on your body. 
Approximately 5 mL of blood (approx. 1 teaspoon) will be collected at various time points 
during a study visit.  
• 
Concomitant Medication review: you will be asked if you have recently taken any 
medications.  
• 
Adverse Events: You will be asked about how you are feeling (whether you feel alright, 
different from normal or unwell) at regular intervals, please tell a study team member if you 
have any changes in your health or concerns. 
You will be discharged from the clinical unit once all study procedures are complete and the clinical 
staff sees no changes in your health which would prevent your discharge from the clinical unit.  
 
Follow up visits 
Following discharge on Day 4, you will be required to attend the Centre for Clinical Studies on three 
separate occasions, Day 7, 14, and 21.  
  
The study doctor will ask you to return to the research unit on these days and may ask you to return 
after this period, if he feels it is necessary. In the event it is necessary to further evaluate the safety 
or effects of the medication, it may be necessary to have access to additional information about 
your health status. Your study doctor may attempt to obtain study-related information about your 
health from you or from other sources, including your primary care physician. This may include 
contacting you again by phone or letter. 
 


Study Drug- LSALT peptide 
 
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The table below outlines the assessments that will be performed during part 3 (Multiple Ascending Dose) cohort of the study: 
 
Study Day 
Screening 
-29 to -2 
-1 
1 
2 
3 
4 
7 
14 
21 
In patient period 
 
X 
X 
X 
X 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Examination 
X 
X 
 
X 
X 
X 
X 
X 
X 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
Drugs of Abuse urine 
sample 
X 
X 
 
 
 
 
 
 
 
Urinalysis 
X 
X 
 
X 
 
X 
X 
X 
X 
Complete blood count 
(CBC) 
X 
X 
 
X 
 
X 
X 
X 
X 
Chemistry 
X 
X 
 
X 
 
X 
X 
X 
X 
Creatinine/eGFR 
X 
X 
 
X 
 
X 
X 
X 
X 
LFTs- Liver function test 
(blood sample) 
X 
X 
 
X 
 
X 
X 
X 
X 
PK 
 
 
X 
X 
X 
X 
X 
 
 
INR/PTT blood sample 
for ( blood clotting 
ability) 
X 
 
 
X 
 
X 
X 
 
 
Chest X-ray 
X 
 
 
 
 
X 
 
 
 
Electrocardiogram ECG 
X 
X 
X 
X 
X 
X 
 
 
X 
B-hCG (blood sample for 
pregnancy test) 
X 
X 
 
 
 
 
 
 
X 
Adverse Event 
X 
 
X 
X 
X 
X 
X 
X 
X 
Anti-Drug Antibodies 
 
 
 
 
 
 
 
X 
 
LSALT Administration 
 
 
X 
X 
X 
 
 
 
 
Discharge from unit 
 
 
 
 
 
X 
 
 
 
Follow up 
 
 
 
 
 
 
X 
X 
X 
 
 
Key; LFT= liver function tests. PK= pharmacokinetic, INR/PTT=blood clotting ability, B-hCG= pregnancy test  
 


 
 
 
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4. 
What do I have to do? 
It is important for your own safety that you inform the study doctor or staff of your complete 
medical history and all medications, supplements, and/or herbal preparations that you have 
taken within the past 6 months or are currently taking. If you have any health problems, please 
notify your study doctor immediately. As mentioned earlier in this document, if you notice any 
changes in your health or have concerns during your participation in the study, also inform 
your study doctor or study staff as soon as possible. So long as you continue to participate, 
you should take the study drug as directed. You must always follow the instructions of the 
study doctor and staff. 
Please note that in the days leading up to your admission to the clinical unit, there are a few 
things you must avoid to be included in the study:  
• 
You should not have participated in other clinical trials within 1 month before signing 
this consent form. 
• 
You should not have donated blood within 60 days before admission into the unit. 
• 
You will be asked to come to the Centre for Clinical Studies in fasting condition (no 
consumption of any food or drinks, with the exception of water, during the 8 hours prior 
to arrival), at admission to the clinical unit and at the follow-up visit. During your stay 
in the clinical unit, you should follow the instructions of the study staff concerning your 
intake of food and beverages. 
• 
Please do not take any prescription medication for 2 weeks prior to your admission to 
the clinical unit.  
• 
Please do not take any over the counter medication for 7 days prior to admission. 
Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day 
respectively) are acceptable. Routine vitamins and supplements are permissible at the 
discretion of the investigator. Please ask if you have any questions.  
• 
Social and light smokers (up to 10 cigarettes per day) are allowed to enter the study, 
however they must agree and be able to abstain from smoking for the full inpatient 
period.  
• 
Please do not consume any caffeine, quinine (tonic water) and xanthine containing 
beverages (tea, coffee, cola, chocolate) for 48 hours prior to your screening 
appointment and 48 hours prior to your admission to the clinical unit. Consumption of 
quinine, caffeine and xanthine containing beverages is not allowed throughout the 
clinical stay. Please ask your study doctor if you have any questions regarding the 
above restrictions.  
• 
Please do not consume alcohol for 48 hours prior to your admission to the clinical unit 
until after your final visit.  
• 
Please do not perform any strenuous exercise for 2 days prior to your admission to the 
clinical unit and until after your final visit. 
• 
You should not have donated blood in the 2 months prior to starting the study and 
should refrain from donating blood during the study and within 2 months after your final 
visit. If you donate blood after this period, you must inform donor centre staff that you 
have recently been involved in a clinical study.  
Please note that you will not be allowed to smoke while at the study centre. 
In case of emergency, you must be easily contactable by phone and/or email. You will be 
given a Participant Wallet Card which contains emergency contact information and information 
about your study commitments. You must carry the Participant Wallet Card with you at all 
times until the end of the study. 


 
 
 
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5. 
Other relevant information about the research study 
This study is being conducted at the Centre for Clinical Studies in Australia. There are no 
researchers from other organisations working in collaboration. 
A representative of Arch Biopartners Inc (study sponsor) may be present for inspections in the 
unit during the study.  
 
6. 
Do I have to take part in this research study? 
Participation in any research study is voluntary. If you do not wish to take part, you don’t have 
to. If you decide to take part and later change your mind, you are free to withdraw from the 
study at any time without providing any reason. Your study doctor may ask you the reason for 
your withdrawal, you can answer or not.  
Your decision whether to take part or not, or to take part and then withdraw, will not affect your 
relationship with the Centre for Clinical Studies and will not involve any penalty or loss of 
benefits to which you would be otherwise entitled. Should you withdraw from the study before 
the final visit you may receive a partial payment according to the number of visits you have 
attended. 
Before you make your decision, a member of the research team will be available so that you 
can ask any questions you have about the research study. You can ask for any information 
you want. Sign the Consent Form only if you agree to participate and only after you have had 
a chance to ask your questions and have received satisfactory answers. 
 
7. 
What are the alternatives to participation? 
Since this study is intended only to evaluate the safety, tolerability and pharmacokinetics of 
LSALT peptide, your alternative to be a volunteer in this study is to choose not to participate 
in the study. 
 
8. 
What are the possible benefits of taking part? 
If you agree to take part in this study, there will be no direct benefit to you. However, your 
participation in this study may help develop important scientific knowledge that could 
contribute to the development of this medication for kidney diseases. We hope the information 
learned from this study will benefit others in the future. 
 
9. 
What are the possible risks and disadvantages of taking part? 
LSALT peptide is an experimental medication, therefore the risks to human participants have 
not been fully evaluated. 
Medical treatments often cause side effects. You may have none, some or all of the effects 
listed below, and they may be mild, moderate or severe. If you have any of these side effects, 
or are worried about them, talk with a study doctor. Your doctor and study staff will also be 
watching you closely for side effects. 
Many side effects go away shortly after treatment ends. However, sometimes side effects can 
be serious, long lasting or permanent. If a severe side effect or reaction occurs, your doctor 
may need to stop your treatment. Tell your study doctor or site staff if you notice any changes 
in your health or have concerns.  Your study doctor will discuss the best way of managing any 
side effects with you. 


 
 
 
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There may also be side effects that are not expected or are not known that may be serious. 
Tell your doctor immediately about any new or unusual symptoms or changes in your health 
that you become aware of. The treatment of the side effects will depend on the type and 
severity of the symptom(s). 
If during screening or participation in this research study a previously unknown medical 
condition is discovered the study doctor will discuss: 
• 
whether you are eligible for study participation  
• 
if you require referral to your usual physician or to a specialist 
 
Risks of Study Drug: 
Currently, the risks of LSALT peptide in humans are unknown. There may be side effects 
related to the infusion of the drug such as lightheadedness, nausea or an allergic reaction. In 
animals, these infusion related side effects were easily treated with anti-histamines. However, 
the drug will be given at much lower doses than the amount administered to animals, and will 
be infused very slowly to minimize these side effects.There is also a small risk that you may 
develop antibodies against the the LSALT peptide which may cause some medical problems, 
especially if you were to receive the drug again in the future. 
Blood Draw/ Cannula Insertion Risks: 
You may have pain or bruising at the site where blood is drawn or a cannula (a temporary 
small plastic tube) is inserted. An infection at the site of blood draws or cannula insertion is 
also possible. The insertion of the cannula (small plastic tube) or the drawing of blood may be 
associated with some pain. Possible side effects from blood drawing include faintness, 
inflammation of the vein, pain, bruising or bleeding at the site of puncture. These will normally 
disappear a few days after the procedure.  
 
Blood Pressure Measurement Risks: 
There is no risk to your health when having your blood pressure tested. You may experience 
some feeling on discomfort as the cuff inflates and squeezes your arm, but it should only last 
a few seconds. Sometimes, there are tiny red spots that appear after the test just below the 
location of the cuff, they should be painless.  
 
Electrocardiogram (ECG) risks: 
The ECG test is a recording of the electrical activity of your heart. The sticky pads used may 
be cold when applied and sometimes cause some discomfort such as redness or itching. If 
there is hair in the area where patches need to be applied, this area will be shaved in order to 
complete the ECG. Shaving may result in irritation. 
 
Risks of Chest X-ray (Radiation Risk) 
This research study involves exposure to a very small amount of radiation. As part of everyday 
living, everyone is exposed to naturally occurring background radiation and receives a dose 
of about 2 millisieverts (mSv) each year. The effective dose from this study is about 0.04 mSv. 
At this dose level, no harmful effects of radiation have been demonstrated as any effect is too 
small to measure. The risk is believed to be minimal.  
Have you been involved in any other research studies that involve radiation? If so, please tell 
us. Please keep information contained within the Patient Information and Consent Form about 
your exposure to radiation in this study, including the radiation dose, for at least five years. 
You will be required to provide this information to researchers of any future research projects 
involving exposure to radiation. 


 
 
 
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Allergic Reaction Risks: 
There is a risk of allergic reaction. If you have a very serious allergic reaction, you may be at 
risk of death.  
Symptoms may include difficulty in breathing, dizziness, itching, swelling of the lips, tongue or 
throat, coughing, rash. 
In general, most symptoms are manageable. They are mild to moderate in severity. But life-
threatening reactions may occur at any drug dose. If you believe you are having a serious 
allergic reaction, you should seek emergency medical assistance immediately. 
Please notify the study doctor immediately if you experience any of these symptoms. Some 
symptoms of allergic reactions are: 
• 
Rash 
• 
Wheezing and difficulty breathing 
• 
Dizziness and fainting 
• 
Swelling around the mouth, throat or eyes 
• 
Fast pulse 
• 
Sweating 
You will be monitored very carefully for any signs or symptoms that you may be having an 
allergic reaction and appropriate care will be taken by the study doctor and nursing staff.  
If you do not understand what some of these side effects or risks mean, ask the study doctor 
or the study staff to explain them to you. 
Pregnancy Risk:  
The risks of the study drug to an unborn child or nursing infant are unknown and may be 
hazardous. It is important that you use the appropriate forms of birth control as described 
below:  
If you are male, you must be either vasectomised, sexually abstinent (when this is in line with 
your preferred and usual lifestyle) or agree to use a condom. If you use a condom and your 
partner is of childbearing potential, she must use another method of contraception resulting in 
a highly effective method of birth control for the full duration of the study and for 3 months after 
the last dose of study drug. 
 
If you are female and of childbearing potential, you must also use a double barrier method of 
contraception for at least 90 days after the last dose of study drug.  
 
Double barrier contraception is defined as a condom AND one of the following; 
• 
Birth control pills (The Pill) 
• 
Birth Control Patch (e.g. Ortho Evra) 
• 
NuvaRing® 
• 
Depot or injectable birth control 
• 
IUD (Intra Uterine Device) 
• 
Documented evidence of surgical sterilization at least 6 months prior to screening 
visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. 
 
Please ask you study doctor if you have any questions regarding the forms of birth 
control that must be used while participating in this study. 
If you are male, you must not donate sperm for at least 90 days after last dose of study drug. 
If you/your partner becomes pregnant during the study or up to 90 days after the last dose of 
study drug please tell your study doctor or staff immediately as we would like to request 


 
 
 
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AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 12 of 21 
permission to follow this pregnancy and its outcome. The study doctor will also report the 
pregnancy to the Human Research Ethics Committee and to the study Sponsor.  
Allowing the pregnancy and outcome to be followed is optional. If your partner agrees to have 
this pregnancy followed, then she will be asked to sign a separate Pregnancy Follow-Up 
Participant Information and Consent Form. The information collected is similar to that which 
would be routinely collected during a typical pregnancy consultation. The consultation will be 
done in person at the Centre for Clinical Studies, and/or by telephone.  
In addition, she will be asked to notify the study doctor about the outcome of the pregnancy. 
If she forgets, she will be contacted to obtain this information. This outcome data collected 
includes: pregnancy complications and outcome, birth weight, birth defects (if any), and 
additional factors that may have had an impact on the outcome of the pregnancy (drugs, 
infections, family history etc.).  
The study doctor may also need to contact the gynecologist of your partner. 
 
10. 
What will happen to my test samples? 
By consenting to take part in this study, you also consent to the collection and testing of your 
urine and blood samples for this research. The total volume of blood taken for the entire study 
is approximately 290ml (approx. 1 cup). For comparison, a standard blood donation is 
approximately 470mL (approx. 2 cups). Additional blood samples may also be collected for 
safety reasons.  
The blood and urine samples collected for the assessment of your health status (e.g. liver and 
kidney function tests) will be processed by a local pathology laboratory. These samples will 
be labelled with your unique study participant number, your initials and date of birth, and will 
not contain any information that can identify you personally. These samples will be destroyed 
following analysis. 
This research project involves the collection of information about your use of drugs and 
alcohol. Participation in the research project includes blood and urine analysis to determine 
the presence of drugs such as amphetamines, methamphetamines, benzodiazepines, 
barbiturates, marijuana, cocaine, PCP, methadone, opioids (narcotics). The test may reveal 
that you have previously used illegal drugs. That information will be stored in a re-identifiable 
(or coded) format. This is a study requirement and the results will remain confidential. In the 
event that the Centre for Clinical Studies is required to disclose that information, it may be 
used against you in legal proceedings or otherwise. If you test positive for any drugs of 
addiction, you will not be able to participate in this study. 
You will receive information and counselling before the HIV and hepatitis tests. If a test shows 
you have HIV or hepatitis you will not be included in this study, but you will have follow-up 
counselling and medical advice. If your test results are positive, the researchers are required 
by law to notify the Victorian government. Signing the consent form means you agree to have 
this testing. It will not be done without your consent. 
Blood samples taken for pharmacokinetics will be sent to various Sponsor-approved 
laboratories in Canada. These samples will be labelled with your unique study participant 
number and will not contain any information that can identify you personally. These samples 
will be stored during the study at a secure premise and the samples will be destroyed following 
analysis at the end of the study. 
 
11. 
What if new information arises during this research study? 
Sometimes during the course of a research study, new information becomes available about 
the treatment that is being studied. If this happens, your study doctor will tell you about it and 
discuss with you whether you want to continue in the research study. If you decide to withdraw, 


 
 
 
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your study doctor will make arrangements for your regular health care to continue. If you 
decide to continue in the research study you will be asked to sign an updated consent form. 
Also, on receiving new information, your study doctor might consider it to be in your best 
interests to withdraw you from the research study. If this happens, he/she will explain the 
reasons and arrange for your regular health care to continue. 
 
12. 
Can I have other treatments during this research study? 
Whilst you are participating in this research study, you are not able to take any medications or 
treatments other than those agreed upon at the start of your participation in the study. It is 
important to tell your study doctor and the study staff, at each clinic visit, about any treatments 
or medications you may have taken, including over-the-counter medications, vitamins or 
herbal remedies, acupuncture or other alternative treatments. 
 
13. 
What if I withdraw from this research study? 
If you decide to withdraw from the study, please notify your study doctor or staff before you 
withdraw. This notice will allow the study doctor to discuss any health risks or special 
requirements linked to withdrawing. 
If you do withdraw your consent during the research study, any information collected on you 
up to the point of withdrawal will be used. Data collected after your withdrawal, if any, may be 
used: 
• If you decide to withdraw from the study, any adverse event not resolved at this time 
will be followed until its resolution by your research doctor to ensure your medical 
follow-up. You may also contact your research doctor if you experience a new adverse 
event. 
• If you withdraw from the study for a reason other than your own decision, your 
research doctor may contact you to request any relevant information and / or 
documentation regarding your medical care. 
• If you withdraw your consent, all your biological sample(s) will be destroyed without 
disclosing your identity. If analysis is required for the study, it will be analysed before 
destroying your samples.   
 
14. 
Could this research be stopped unexpectedly? 
This research study may be stopped unexpectedly for the reasons listed below.   
• 
Unacceptable side effects 
• 
The drug being shown not to be safe 
• 
Decisions made in the commercial interests of the sponsor or by local regulatory/health 
authorities 
• 
If you don’t follow the instructions of the clinical unit staff; or 
• 
If the study doctor decides it is in the best interest of your health and welfare to stop. 
 
15. 
What will happen when the research study ends? 
The study drug will not be available to you following completion of participation.  
The study data will be analysed, and a final report provided to the study doctor, who will share 
the results with you when requested. The disclosure and/or any published results will be 


 
 
 
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available to you when requested. It is usual for a number of years to elapse before definitive 
results of this type of study are available. These may be published in medical journals that are 
available to the public. You should feel free to ask the study staff about this. 
 
Part 2 - How is this study being conducted? 
 
16. 
What will happen to information about me? 
Any information and data obtained/retained in connection with this research study that can 
identify you will remain confidential and will only be used for the purpose of this research study 
and future research related to the pathway being studied and related disease conditions. 
Information about you may be obtained from your health records held at other health services 
for the purpose of this research. By signing the consent form you agree to the study team, 
including Sponsor delegates, accessing health records if they are relevant to your participation 
in this research study to ensure data accuracy. Whilst every effort will be made to keep your 
personal information confidential, the data gathered for this study will also be reviewed by a 
Sponsor delegate. This delegate will have access to your medical records, without violating 
your confidentiality to the extent permitted by local laws and regulations, to verify the data are 
correct and complete. 
The data collected as part of this research study may be reviewed by representatives of the 
international sponsor, Arch Biopartners Inc, its affiliated companies and/or subcontractors, the 
local sponsor, Arch Clinical Pty Ltd, the Research Ethics Committee of Alfred HREC, by 
authorised representatives of the Australian Therapeutic Goods Administration or other 
regulatory agencies. Information may be transferred to parties in countries (and regions) other 
than Australia including the US, and Europe for these purposes. Syneos Health, Arch 
Biopartners Inc representatives, collaborators and contracted agencies comply with internal 
procedures to protect personal information even in countries whose data privacy laws are less 
strict than those of this country. In all cases when dealing with your personal (coded) 
information. Arch Biopartners Inc, and any of their agents will comply with the Privacy Act 
1988. If you have any concerns on how your information is handled, please feel free to ask a 
member of the study team for more information. 
By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Study Medical Records 
Data from your study medical record will be identifiable and stored in secured offices at the 
Centre for Clinical Studies. Only research team members and authorised representatives from 
the Sponsor, the Ethics Committee or regulatory agencies will have access to your medical 
records. 
You have a right to access and request correction to your information. 
 
Case Report Form (CRF) 
Information you provide us will be recorded in electronic case report forms (CRF).  Your 
information will be coded by your unique study number, your gender and birth date only and 
thus will be considered re-identifiable. The recorded data will be kept in an electronic database 
which will be managed throughout the study by Syneos Health who are monitoring the study. 
Information from these CRFs will form part of the study results, which may be published. A 
copy of the CRF entries and your deidentified study medical record will be kept indefinitely 
with all other study related documents. 


 
 
 
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By signing the consent section, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above. 
 
Publications 
A report of the study results may be submitted for publication. In any publication and/or 
presentation, information will be provided in such a way that you cannot be identified, except 
with your permission). 
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you 
have the right to request access to your information collected and stored by the research team. 
You also have the right to request that any information with which you disagree be corrected. 
Please contact the study team member named at the end of this document if you would like 
to access your information. 
If you want to know more about the Centre for Clinical Studies’ approach to privacy or access 
any of your information held by the Centre for Clinical Studies, you can contact Dr Ben Snyder 
or the Centre for Clinical Studies. 
It is desirable that your local doctor be advised of your decision to participate in this research 
study. By signing the consent section, you agree to your local doctor being notified of your 
decision to participate in this research study. 
Information about your participation in this research study may be recorded in your health 
records. 
 
17. 
Complaints and compensation 
If you suffer any injuries or complications because of this research study, you should contact 
the study doctor or study team as soon as possible and you will be assisted with arranging 
appropriate medical treatment. If you are eligible for Medicare, you can receive any medical 
treatment required to treat the injury or complication, free of charge, as a public patient in any 
Australian public hospital. 
There are two avenues that may be available to you for seeking compensation if you suffer an 
injury as a result of your participation in this research study: 
• 
The pharmaceutical industry has set up a compensation process, with which the local 
sponsor of this research study, Arch Biopartners Inc, has agreed to comply. Details of 
this process and conditions are set out in the Medicines Australia Guidelines for 
Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical 
Trial. In accordance with these Guidelines, the sponsor will determine whether to pay 
compensation to you, and if so, how much. The research staff will give you a copy of 
the Guidelines together with this Participant Information and Consent Form. If you have 
any questions about the Guidelines, please contact Dr Ben Snyder on 03 8593 9800. 
• 
You may be able to seek compensation through the courts. 
 
If you are not satisfied with how your personal information has been handled (as laid out in 
the Privacy Act, 1988), then you can make a complaint to the Office of the Australian 
Information Commissioner (OAIC). It is free to lodge a complaint and you do not need a lawyer, 
however if you do decide to hire a lawyer, you must pay for the lawyer yourself. You can 
choose 
to 
withdraw 
your 
complaint 
at 
any 
time. 
Please 
refer 
to 
http://www.oaic.gov.au/privacy/privacy-complaints for more information. 
 
 


 
 
 
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18 
Who is organising and funding the research? 
This research is being conducted by Arch Biopartners Inc based in Canada and in Australia 
by Arch Clinical Pty Ltd. The Clinical research organisation monitoring the study is Syneos 
Health. Arch Biopartners Inc may benefit financially from this research study if, for example, 
the study assists to obtain approval for a new drug. 
By taking part in this research study you agree that samples of your blood (or data generated 
from analysis of these materials) may be provided to Arch Biopartners Inc. 
Arch Biopartners Inc may directly or indirectly benefit financially from your samples or from 
knowledge acquired through analysis of your samples. 
If knowledge acquired through this research leads to discoveries that are of commercial value 
to Arch Biopartners Inc, the study doctors or their institutions, there will be no financial benefit 
to you or your family from these discoveries. 
Arch Biopartners Inc, other researchers, or research companies may patent or sell discoveries 
that result from this research. Neither Arch Biopartners Inc nor the study doctor will compensate 
you if this happens. 
Contractors engaged by Arch Biopartners Inc will receive a payment from Arch Biopartners 
Inc for undertaking this research study. 
No member of the research team will receive a personal financial benefit from your 
involvement in this research study (other than their ordinary wages). 
 
19. 
Will I be reimbursed to take part in this research study? 
If you are eligible to enter the study, you will be reimbursed $75.00 for the screening and 
follow-up visits, and at an hourly rate of $12.50 per hour for the in-clinic stay part of this study. 
The total payment for participants who complete the entire study will be $1,650.  
Regardless of whether you withdraw early or complete the study, you will be reimbursed within 
10 business days of the end of study visit via electronic funds transfer directly into your bank 
account. Should you withdraw from the study before the final visit you will receive a partial 
payment according to the number of visits you have attended.  
Reimbursement compensates for your time, travel expenses, parking and inconvenience. This 
reimbursement is not made for undergoing risk nor is it to compensate you for any loss of 
earnings as a result of your participation. 
It is not anticipated that participation in this research study will result in any additional cost to 
you. 
 
20. 
Who has reviewed the research study? 
All research in Australia involving humans is reviewed by an independent group of people 
called a Human Research Ethics Committee (HREC) who make sure that the rights, safety 
and well-being of participants in a study are protected. The ethical aspects of this research 
study have been approved by The Alfred Ethics Committee. 
This study will be carried out according to the National Statement on Ethical Conduct in Human 
Research (March 2007) produced by the National Health and Medical Research Council of 
Australia. This statement has been developed to protect the interests of people who agree to 
participate in human research studies. 
 


 
 
 
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21. 
Further information and who to contact 
The person you may need to contact will depend on the nature of your query. 
If you want any further information concerning this study or if you have any medical problems 
which may be related to your involvement in the study (for example, any side effects), you can 
contact the principal study doctor (Dr Ben Snyder) on 03 8593 9800 or any of the following: 
General Enquiries:  
1800 243 733 
After hours contact (Centre for Clinical Studies) 24 hours 7 days a week 
On-call mobile:  
0429 353 069 
 
For matters relating to research at the site at which you are participating, the details of the 
local site complaints person are: 
 
Complaints contact person 
Position 
Complaints 
Email 
complaintsofficer@nucleusnetwork.com.au  
Privacy contact person 
Position 
Privacy Officer 
Email 
privacyofficer@nucleusnetwork.com.au  
 
If you have any complaints about any aspect of the study, the way it is being conducted or 
any questions about being a research participant in general, then you may contact: 
Reviewing HREC approving this research and HREC Executive Officer details 
Please reference the following Alfred Project number:  64/19 
 
 
Reviewing HREC name 
Alfred Hospital Ethics Committee 
Position 
Governance Officer,  
Ethics and Research Governance, Alfred Health 
Telephone 
(03) 9076 3619  
Email 
research@alfred.org.au  


 
 
 
Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 18 of 21 
 
 
 
 
CONSENT 
Alfred Project Number: 
64/19 
Full Study Title: 
 A phase I double-blind, placebo-controlled, randomized, intra-
participant single and multiple ascending dose finding study to 
evaluate the safety and pharmacokinetic profile of LSALT 
Peptide in healthy participants 
Protocol Number: 
AB001 
Test Drug Code: 
LSALT peptide 
International Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal Investigator: 
Dr Ben Snyder 
Location: 
Centre for Clinical Studies 
 I am 18 years of age or over 
 I have read the Participant Information Sheet, or someone has read it to me in a 
language that I understand. 
 I understand that my involvement in this study may not be of any direct benefit to me. 
 I have had an opportunity to ask questions and I am satisfied with the answers I have 
received. I have been given the name of a person to contact if I have any questions 
during the study. 
 I have been told that no information regarding my medical history will be divulged to 
unauthorised third parties and the results of any tests involving me will not be published 
to reveal my identity. 
 I understand the purposes, procedures and risks of the research described for this 
study. 
 I give permission for my doctors, other health professionals, hospitals or laboratories 
outside this hospital to release information to the Centre for Clinical Studies for the 
purposes of this study. I understand that such information will remain confidential.  
 I freely agree to participate in this research study as described and understand that I 
am free to withdraw at any stage during the study without prejudice to future treatment. 
If I withdraw from the study, I agree that the information collected about me up to the 
point when I withdraw may continue to be processed.  
 I understand that I will be given a signed copy of this document to keep. 
 
 
 
 


 
 
 
Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 19 of 21 
 
Participant’s Name (printed)  …………………….…Middle Initial..……Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
Witness (only if required) 
Name of Witness to 
Participants signature 
(printed)  …………………….…Middle Initial…..…Surname…….………....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
* Witness is not to be the investigator, a member of the study team or their delegate.  In the event that an 
interpreter is used, the interpreter may not act as a witness to the consent process.  Witness must be 18 years 
or older. 
Declaration by Study Doctor/Senior Researcher 
I have given a verbal explanation of the research study, its procedures and risks and I believe 
that the participant has understood that explanation. 
Study Doctor/Researcher’s 
Name (printed)  ……….………………Middle Initial……..Surname……….……....... 
Signature 
 
 
 
Date _____/______/________ 
Time _____:_____ 
A senior member of the research team must provide the explanation of, and information 
concerning, the research study. 
Note: All parties signing the consent section must date their own signature. 
 
 
 
 
 
 
 


 
 
 
Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 20 of 21 
 
FORM FOR WITHDRAWAL OF PARTICIPATION 
Alfred Project 
Number: 
64/19 
Protocol 
Number: 
AB001 
Full Study Title: 
A phase I double-blind, placebo-controlled, randomized, intra-
participant single and multiple ascending dose finding study to evaluate 
the safety and pharmacokinetic profile of LSALT Peptide in healthy 
participants 
Test Drug 
Code: 
LSALT peptide 
International 
Sponsor: 
Arch Biopartners Inc 
Local Sponsor: 
Arch Clinical Pty Ltd 
Principal 
Investigator: 
Dr Ben Snyder 
Location: Centre for Clinical Studies 
 
Declaration by Participant 
I wish to withdraw from participation in the above research study and understand that such 
withdrawal will not affect my routine treatment, my relationship with those treating me or my 
relationship with the Centre for Clinical Studies. 
Participant’s Name (printed)  ……………………….Middle Initial…..…Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Study Doctor to include a description of the circumstances for withdrawal, if provided by the 
participant. 
 
 
 
Declaration by Study Doctor 
I have given a verbal explanation of the implications of withdrawal from the research study 
and I believe that the participant has understood that explanation. 
 
 


 
 
 
Study Drug- LSALT peptide 
 
AB001 Part 3 MAD PICF V 2.0 06 June 2019  
Page 21 of 21 
Study Doctor/Researcher’s 
Name (printed)  ……………….………Middle Initial……..Surname….…………....... 
Signature 
 
 
Date _____/______/________ 
Time _____:_____ 
Note: All parties signing the consent section must date their own signature. 

Prot_000.pdf: 
Version: 30Jan2020_V3
page 1 of 36
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending 
dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in 
healthy participants
Protocol#:  AB001
Version: 30 Jan2020_V3
Sponsor: Arch Biopartners Inc.
Study Site: Nucleus Network
Principal Investigator (PI): Dr. Ben Snyder
CONFIDENTIAL
The information contained in this document is the property of Arch Cancer Therapeutics, a wholly owned subsidiary of 
Arch Biopartners Inc. All content are regarded as confidential and, except to the extent necessary to obtain informed 
consent or as required by law, may not be used, reproduced, or disclosed to third parties in any form whatsoever without 
written permission from Arch Cancer Therapeutics Inc.  Persons to whom the information is disclosed must be informed 
that the information is confidential and may not be further disclosed as above.


Version: 30Jan2020_V3
page 2 of 36
Protocol Approval Signatures 
Protocol Title: A phase I double-blind, placebo-controlled, randomized, single and 
multiple ascending dose finding study to evaluate the safety and pharmacokinetic 
profile of LSALT Peptide in healthy participants
Protocol Number: AB001
This study will be conducted in compliance with the clinical study protocol (and amendments), International 
Conference on Harmonisation (ICH) guidelines for current Good Clinical Practice (GCP) and applicable 
regulatory requirements.
Sponsor Signatory
Daniel Muruve
Chief Science Officer
Arch Biopartners
545 King Street West
Toronto, Ontario
M5V 1M1, Canada
Signature
Date
Principal Investigator 
Dr Ben Snyder
Nucleus Network
Level 5, Burnet Tower
AMREP Precinct
89 Commercial Road Melbourne 
VIC, 3004
Signature
Date
Medical Monitor
Dr David Fuller
Medical Monitor
Syneos Health
Suite 1, Level 2, 924 pacific Highway
Gordon, NSW, 2072
Australia
Signature
Date
Januray 30, 2020
4th Feb 2020


Version: 30Jan2020_V3
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Study Personnel
Sponsor Personnel
Name: Daniel Muruve
Title: Chief Science Officer, Arch Biopartners
Address: 545 King Street West
Toronto, Ontario
M5V 1M1, Canada
Telephone No: 403-220-2418
Name: Arthur Lau
Title: Project Manager, Arch Biopartners
Address: 545 King Street West
Toronto, Ontario
M5V 1M1, Canada
Telephone No: 403-220-2418
Other Personnel
Medical Monitor Syneos Health 
Name:
Dr. David Fuller
Title:
Medical Monitor
Address:
Syneos Health
Suite 1, Level 2, 924 Pacific Highway
Gordon, NSW, 2072
Australia
Telephone No.:
+61 450 965 709


Version: 30Jan2020_V3
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Project Manager
Name:
Emma Field
Title:
Senior Project Manager
Address:
Syneos Health
Suite 1, Level 2, 924 pacific Highway
Gordon, NSW, 2072
Australia
Telephone No.:
+61 (0)284379247
Clinical Laboratory/Medical/Technical Department(s)
Company Name: Syneos Health Bioanalytical Lab
Address:
2500 Rue Einstein
Quebec City
Quebec G1P0A2
Telephone No.:
1 418 527 4000


Version: 30Jan2020_V3
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TABLE OF CONTENTS
1.0
SYNOPSIS........................................................................................................................... 7
2.0
LIST OF ABBREVIATIONS.............................................................................................. 7
3.0
BACKGROUND AND RATIONALE................................................................................ 7
3.1 
Inflammation and Organ Injury........................................................................................ 7
3.2 
Acute Kidney Injury......................................................................................................... 8
3.3 
LSALT Peptide ................................................................................................................ 9
3.4
Pre-Clinical Data for Dipeptidase-I and LSALT Peptide in Acute Kidney Injury........ 10
3.5
Drug Metabolism and Pharmacokinetics ....................................................................... 12
3.6 
Toxicology and Safety ................................................................................................... 12
3.7 
Study Rationale .............................................................................................................. 14
4.0
OBJECTIVES.................................................................................................................... 15
4.1 
Primary Objective .......................................................................................................... 15
4.2 
Secondary Objective ...................................................................................................... 15
5.0
STUDY DESIGN............................................................................................................... 15
6.0
PATIENT SELECTION.................................................................................................... 16
6.1 
Inclusion Criteria............................................................................................................ 16
6.2 
Exclusion Criteria........................................................................................................... 16
6.3 
Enrollment and Randomization...................................................................................... 17
6.4 
Blinding.......................................................................................................................... 17
6.5 
Inclusion of Women and Minorities............................................................................... 17
7.0
STUDY PROCEDURES ................................................................................................... 17
7.1 
Single Ascending Dose (SAD) Cohort........................................................................... 17
7.2 
Multiple Ascending Dose (MAD) Cohort...................................................................... 22
7.3 
Investigational Drug Product, Monitoring and Safety Procedures ................................ 24
8.0
DOSE ESCALATION AND STOPPING RULES............................................................ 26
9.0
REGULATORY AND REPORTING REQUIREMENTS ............................................... 26
9.1 
Adverse Events (AEs).................................................................................................... 26
9.2
Severity (Intensity)......................................................................................................... 26
9.3 
Assessment of Causality................................................................................................. 27
9.4 
Expectedness.................................................................................................................. 27
9.5 
Serious Adverse Events (SAEs)..................................................................................... 27
9.6 
Pregnancy....................................................................................................................... 28
9.7 
Reporting of Serious Adverse Effects............................................................................ 28
9.8 
Protocol Exceptions........................................................................................................ 29
9.9 
Unblinding...................................................................................................................... 29
10.0
PHARMACEUTICAL INFORMATION.......................................................................... 29
10.1 LSALT Peptide .............................................................................................................. 29
11.0
MONITORING AND QUALITY ..................................................................................... 30
12.0
AUDIT AND INSPECTION............................................................................................. 30
13.0
ETHICS, REGULATORY, INFORMED CONSENT AND PATIENT 
CONFIDENTIALITY................................................................................................................... 30
13.1 Independent Ethics Committee or Institutional Review Board...................................... 30


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13.2 Regulatory Authorities................................................................................................... 30
13.3 Ethical Conduct of the Study ......................................................................................... 31
13.4
Informed Consent........................................................................................................... 31
13.5
Subject Confidentiality................................................................................................... 31
14.0
DATA AND SAFETY MONITORING............................................................................ 32
15.0
PHARMACOKINETIC STUDIES ................................................................................... 32
16.0
STATISTICAL ANALYSIS ............................................................................................. 32
17.0
RECORD RETENTION.................................................................................................... 32
18.0
SCHEMA........................................................................................................................... 34
19.0
REFERENCES .................................................................................................................. 35


Version: 30Jan2020_V3
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1.0
SYNOPSIS
Inflammation resulting from infection or injury leads to tissue damage and eventually organ 
dysfunction/failure due to the effects of recruited immune cells. This process is regulated by many 
biological events which include the recruitment and adhesion of circulating leukocytes to 
endothelial cells prior to infiltration of the target tissue. Dipeptidase-1 is a common receptor that 
regulates the adhesion of circulating leukocytes to endothelial cells. 
LSALT is a 16 amino acid peptide drug and a selective non-enzymatic dipeptidase-1 antagonist.  
LSALT peptide prevents leukocyte adhesion to endothelial cells creating numerous indications for 
targeting inflammation in the context of microbial and non-microbial (sterile) tissue injury. In pre-
clinical mouse models, LSALT peptide has proven efficacious in preventing acute kidney injury 
induced by ischemia-reperfusion, toxins and sepsis. LSALT peptide has a favorable toxicology 
profile with little drug-related toxicity observed in animal studies. This is a first-in-human phase I 
clinical study to evaluate the safety and pharmacokinetics of single and multiple ascending doses 
of the LSALT peptide.
2.0
LIST OF ABBREVIATIONS
AKI
acute kidney injury
API
active pharmaceutical ingredient 
ARDS
acute respiratory distress syndrome
DPEP-1
dipeptidase-1
GPI
glycosylphosphatidylinositol
IRI 
ischemia reperfusion injury
IV
intravenous
LAL
limulus amebocyte lysate
LPS
lipopolysaccharide
MAD
multiple ascending dose
MTD
maximum tolerated dose 
NOAEL
no observed adverse effect limit
PK
pharmacokinetics
SAD
single ascending dose
SRC
safety review committee
3.0
BACKGROUND AND RATIONALE
3.1 Inflammation and Organ Injury
Inflammation is a common pathway that contributes to the pathogenesis of many diseases 
caused by infection, allograft rejection, hypoxia, and autoimmunity. Although 
inflammation is regulated by many complex biological processes and can be activated by 
numerous microbial and non-microbial stimuli, a common framework of events exists 
regardless of disease context which includes activation of pattern recognition receptors, 
upregulation of pro-inflammatory cytokines, and recruitment of leukocytes to affected 
tissues1-3. The interactions between recruited leukocytes and endothelial cells has been 
studied in detail to understand the exact processes that allows immune cells to bind to and 
infiltrate into injured or infected tissues. Endothelial receptors for leukocyte adhesion 


Version: 30Jan2020_V3
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including various selectins (e.g. E-selectin), integrins and members of the 
immunoglobulin family (e.g. PECAM1) have been identified however other unknown 
receptors remain. Although inflammation is beneficial in eliminating microorganisms, 
abnormal and damaged cells during disease, it can also cause organ dysfunction and failure 
due to an excessive or unrelenting response that involves the overproduction of cytokines, 
cytotoxicity and cell death4.
3.2 Acute Kidney Injury
Acute kidney injury is an example where excessive inflammation triggered by toxins or 
reduced renal blood flow results in organ failure. Acute kidney injury is a significant 
clinical problem for which no specific therapies, aside from supportive care, currently 
exist. Patients who experience acute kidney injury in several contexts are at higher risk of 
cardiovascular events, end-stage kidney disease and death5.
1.2.1. Renal Ischemia Reperfusion Injury During Cardiac Surgery. Acute kidney injury 
(AKI) occurs in 30% of patients that undergo cardiac surgery with 1% of patients requiring 
dialysis6. Acute kidney injury represents an additional challenge in patients recovering 
from cardiac surgery as they have higher incidences of mortality, complications in 
treatment course, and higher risk of complications such as cardiovascular events and 
infection. Of the patients that require dialysis because of cardiac surgery-associated AKI, 
many will require lifelong dialysis which increases overall morbidity and mortality. 
During cardiac surgery, reduction in renal blood flow leads to ischemia and tissue injury 
in the kidney which triggers and inflammatory response. Recruited inflammatory cells 
adhere to activated endothelium leading to cellular injury and further pro-inflammatory 
responses ultimately causing further tissue injury and renal dysfunction. Even though renal 
inflammation is well documented as having a prominent role in cardiac surgery induced 
AKI6, there is currently no specific therapies that target this condition. As an inhibitor of 
leukocyte activation/recruitment during inflammation, LSALT peptide is a novel 
therapeutic that may protect the kidneys from the consequences of ischemia and prevent 
AKI in patients undergoing cardiac surgery. This will be the first indication developed for 
LSALT peptide.
1.2.2.
Sepsis-associated Acute Kidney Injury. Sepsis represents a systemic host 
inflammatory response to infection. Excessive inflammation leads to multi-organ 
dysfunction that includes acute kidney injury, shock liver and acute respiratory distress 
syndrome (ARDS)7. Incidence rates for severe sepsis is estimated at 50-300 per 100,000 
population in the United States where half of those cases occur in the ICU8,9. Sepsis has a 
high rate of mortality where up to 50% of patients will have septic shock. Of the patients 
undergoing sepsis, it is estimated as many as 60% of those patients will develop sepsis-
associated AKI with the elderly, women, and patients with co-morbidities such as chronic 
kidney disease, heart failure, or liver disease at higher risk. Similarly, liver 
dysfunction/failure can occur in up to 40% of patients with sepsis10. When sepsis affects 
the lung, 10% of septic patients can develop acute respiratory distress syndrome (ARDS) 
which is a life-threatening situation in which leaky blood vessels in the lungs compromise 
its ability to absorb oxygen11. This has downstream effects on many other organs due to 
the hypoxic injury that may occur due to the low oxygen environment. In septic patients 
that experience organ dysfunction, the incidence of morbidity and/or mortality is 


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significantly increased. Sepsis associated organ dysfunction is driven by a multi-faceted 
pathophysiological process including ischemic injury due to variations in hemodynamics, 
systemic cytokine-mediated inflammation, and subsequent cellular injury. The current 
standard of care aims to treat the underlying infection and provide physiologic support 
(such as mechanical ventilation and dialysis) for injured and failing organs. No specific 
therapy exists to protect the kidney and other organs from the deleterious effects of the 
inflammatory response and the associated long-term consequences (chronic kidney 
disease, chronic lung disease, etc). LSALT peptide provides a unique strategy to 
specifically block leukocyte recruitment and dampen the inflammatory response in these 
organs during sepsis which may preserve organ function and ameliorate long-term sepsis-
associated morbidity and mortality.
1.2.3. Delayed Allograft Function and Kidney Transplantation. Ischemia reperfusion 
injury (IRI) is an unavoidable obstacle inherent to organ preservation and surgery during 
solid organ transplantation. As previously described, renal IRI results in a robust 
inflammatory response in the kidney through activation of an innate immune response. 
Research has shown delayed allograft function attributed to prolonged cold ischemia 
results in the loss of tubular cell mass and endothelial dysfunction in addition to enhanced 
graft immunogenicity12. Together, the ischemia-reperfusion injury associated with 
prolonged cold ischemia has a negative impact on both short- and long-term kidney 
allograft outcomes. Various therapies have been suggested including interfering with 
leukocyte adhesion which would reduce the level of inflammation in the allograft and 
prevent delayed graft function13. As a leukocyte adhesion inhibitor, LSALT peptide could 
provide protection against pro-inflammatory responses in the allograft either as an additive 
to the perfusion solution or given pre- and post-operatively to the recipient. This would 
prevent delayed allograft function and improve allograft survival.
1.2.4. Contrast-induced acute kidney injury (CI-AKI). CI-AKI occurs following the 
intravenous or intra-arterial administration of radiographic contrast agents for diagnostic 
imaging. Radiographic contrast is a known kidney toxin, and although the incidence rate 
of CI-AKI is low among patients with normal kidney function, patients with pre-existing 
kidney disease or heart failure have 2-3-fold increased risk14-16. Patients with CI-AKI 
experience a greater risk of cardiovascular events, chronic kidney disease requiring 
dialysis and mortality14,15. The incomplete understanding of the pathogenesis of CI-AKI 
has hampered the development of any effective strategies for the prevention of this 
complication. As above, pre-clinical studies have identified a substantial role for renal 
inflammation in the pathogenesis of CI-AKI. LSALT peptide represents a unique 
treatment strategy to prevent CI-AKI in high risk patients undergoing angiography 
procedures.
3.3
LSALT Peptide
LSALT is a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH. LSALT 
peptide binds to DPEP-1 but does not inhibit its biologic enzymatic activity potentially 
minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte 
recruitment in multiple experimental disease models through the direct inhibition of 
leukocyte adhesion to DPEP-1. DPEP-1 represents a new molecular pathway for leukocyte 


Version: 30Jan2020_V3
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adhesion discovered by Arch scientists. Intellectual property and clinical development of 
LSALT peptide is currently assigned to Arch Biopartners Inc.
LSALT peptide was discovered by using an unbiased in vivo approach where a combinatorial 
phage display library17 was used to isolate specific peptide-displaying-phage that homed to 
the liver and lungs of mice during an inflammatory condition. In brief, neutrophils were 
isolated from C57/BL6 mice. RNA isolated from these neutrophils were then converted into 
cDNA. These neutrophil derived cDNA’s were then fused into the coat protein gene of T7 
phage thereby generating a library called T7N. This resulted in a random pool of T7 phages 
which presented various neutrophil peptides on the surface. These phage display libraries 
were subtracted by depleting the phage that bound to background cells or primary murine 
unstimulated lung endothelium. Unbound phage were then isolated from the culture and 
injected into neutrophil-depleted mice after lipopolysaccharide (LPS) stimulation. Phage 
that bound to the lung and liver endothelium were recovered, isolated and re-injected into 
another group of mice to enrich for the specific homing phage. This process was repeated 
five times in vivo to identify enriched phage clones that specifically homed to the lungs and 
liver. After isolation, phage were screened on the basis of their ability to inhibit neutrophil 
recruitment in the liver sinusoids in the presence of LPS by intravital microscopy. A specific 
peptide-displaying phage was isolated that inhibited the adhesion of neutrophils in the liver 
sinusoids in response to LPS in vivo. This phage subclone expressed the peptide NH3-
LSALTPSPSWLKYKAL-COOH and designated as LSALT peptide. 
3.4 Pre-Clinical Data for Dipeptidase-I and LSALT Peptide in Acute Kidney Injury
1.4.1. DPEP-1 expression and function in kidney, liver, and lung. DPEP-1 expression and 
localization was characterized in renal tubular epithelial cells (TEC) cultured from human 
nephrectomy tissue samples were labeled with either zonula occludens-1 (ZO-1), a tight 
junction protein found on TEC, and DPEP-1. Confocal microscopy confirmed the expression 
of DPEP-1 on the surface of TEC. Additional characterization of DPEP-1 using 
immunohistochemical analysis revealed high expression levels in mouse kidney epithelium 
and endothelium as well as expression in lung and liver endothelium. Similar expression 
patterns have been confirmed in human lung, liver and kidney. Using immunoblotting, 
DPEP-1 expression was found in both total kidney lysates and isolated TEC which 
confirmed the microscopy findings. Although DPEP-1 is predicted to have a size of 42kDa, 
a 55kDa DPEP-1 protein was also detected due to the presence of a GPI anchor as well as 
post-translational glycosylation as demonstrated by the by the effects of PNGaseF.
Functional activity of DPEP-1 was determined in various samples using fluorescent enzyme 
activity assay that demonstrated high levels of dipeptidase activity in both human and mouse 
kidney tissue.
1.4.2. Specificity of LSALT Peptide binding to DPEP-1. DPEP-1 as a binding target for 
LSALT peptide was confirmed by overexpressing rat, canine or human DPEP-1 in Cos-1
cells and treated with fluorescently labeled LSALT peptide. Analysis with fluorescent 
confocal microscopy of these cells demonstrated that LSALT peptide was bound only to 
cells expressing DPEP-1. This specific interaction was confirmed using a biotin-labeled 
LSALT peptide immunoprecipitation assay of DPEP-1. Total protein lysates from DPEP-1
overexpressing cells were treated with biotin-labeled LSALT peptide and the protein 
complex was pulled down with neutravidin conjugated beads before analysis by 


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immunoblotting using anti-DPEP-1 antibody. Immunoblot analysis revealed that DPEP-1
interacted with LSALT peptide but not non-specific control peptide indicating specificity of 
LSALT peptide binding to DPEP-1.
To ensure LSALT peptide would not target similar proteins, other members of the 
dipeptidase family were also assessed. Human DPEP-1, DPEP-2, and DPEP-3 were 
transiently expressed in Cos-1 cells before being treated with fluorescent-labeled LSALT 
peptide. Analysis by fluorescent microscopy revealed that LSALT peptide bound to DPEP-
1 expressing cells but not DPEP-2 or DPEP-3 expressing cells.
DPEP-1 enzyme activity was tested using a fluorometric assay originally described by 
Heywood and Hooper in 199518. Enzymatic activity of DPEP-1 was confirmed in lysates 
from human, rat, and mouse derived DPEP-1 expressing cells. Cilastatin or penicillamine,
known functional inhibitors of DPEP-1, abrogated the enzymatic activity of both human and 
mouse DPEP-1. When cells expressing human DPEP-1 were treated with LSALT peptide, 
no significant decrease in DPEP-1 enzymatic activity was detected indicating that LSALT 
peptide binds to DPEP-1 but does not inhibit its enzymatic activity. 
To determine whether the catalytic region of DPEP-1 was required for LSALT peptide 
interaction, a catalytically inert human DPEP-1 (E141D) was transiently expressed in Cos-
1 cells and treated with fluorescent LSALT peptide. Analysis by fluorescent microscopy 
demonstrated removal of catalytic activity had no effect on LSALT peptide binding on cells 
as compared to normal DPEP-1 or negative mutant control (H215). Loss of enzymatic 
activity in the catalytically inert DPEP-1 (E>D) was confirmed using the fluorometric 
assay13. Protein expression level of catalytically inert DPEP-1 (E141D) in Cos-1 cells was 
also confirmed by immunoblotting.
In a human in vitro static neutrophil adhesion assay, LSALT peptide inhibited neutrophil 
1.4.3.
DPEP-1 plays a role in renal ischemia reperfusion injury.
Renal 
ischemia/reperfusion injury (IRI) is a major cause of acute kidney injury (AKI). A reduction 
in renal blood flow followed by reperfusion during patient recovery occurs in numerous 
clinical contexts including cardiac surgery and kidney transplantation. Renal IRI results in 
inflammation that includes leukocyte infiltration, renal hemorrhage, and tubular cell 
necrosis.  Inflammation plays a significant role in the pathophysiology of renal IRI, however 
there are currently no therapeutic strategies in human AKI that directly target this pathway. 
To determine the potential impact of LSALT peptide in renal IRI, a survival model of murine 
renal IRI was employed where a vascular clamp is placed on the renal pedicle of a unilateral 
nephrectomised mouse to induce warm ischemia and subsequently released to induce 
reperfusion injury.  A significant inflammatory response can be observed in the kidney as 
early as 2 hours of renal IRI with large numbers of monocytes and neutrophils infiltrating 
into the tubular/interstitial space. Furthermore, because of immune cell infiltration and 
extravasation, loss of endothelial integrity can also be observed as blood vessels become 
leaky and no longer retain their web-like organization.
Phenotypically, mice undergoing renal IRI developed oliguria/anuria over the course of 2 
days due to loss of kidney function measured as an increase in serum creatinine. Treatment 


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of mice with LSALT peptide (10 µg/kg) prior to renal IRI ameliorated AKI allowing mice 
to maintain normal urine output and preserving renal function. A similar effect on acute 
kidney injury was also seen with cilastatin (35 µg/kg), a chemical inhibitor of DPEP-1, albeit 
less effective than LSALT peptide. Furthermore, dose response experiments demonstrated 
that LSALT peptide effectively inhibited the inflammatory response to renal IRI at a dose as 
low as 100ng/kg.
Use of another DPEP-1 targeting peptide, GFE-117 (10 µg/kg), also demonstrated protection 
against renal IRI induced inflammation in a similar manner as LSALT peptide (10 µg/kg).
1.4.4. DPEP-1 is a key molecule in contrast induced acute kidney injury. Radiographic 
contrast agents for diagnostic imaging are renal toxins that can induce acute kidney injury 
(CI-AKI). Inflammation plays a major role in the pathogenesis of CI-AKI. To determine if 
DPEP-1 inhibition using LSALT peptide or cilastatin could protect against CI-AKI, a mouse 
model was employed. Mice were volume depleted by water deprivation for 48 hours to 
induce pre-renal azotemia. Mice were then administered intravenous iodinated contrast agent 
(ioversol) and followed for 72 hours. In untreated mice, intravital microscopy revealed the 
recruitment of inflammatory monocytes and neutrophils at 6h resulting in tissue damage and
AKI by day 3. Treatment with LSALT peptide (10 µg/kg) and cilastatin (35 µg/kg) prior to 
contrast administration reduced renal inflammation at 6 hours. Phenotypic studies 
demonstrated that mice treated with contrast agent developed anuria/oliguria over the course 
of 3 days and impaired renal function reflected by increased serum creatinine while LSALT 
peptide and cilastatin preserved urine output and prevented AKI in mice receiving ioversol 
at 3 days. LSALT peptide and cilastatin administered together did not provide any additive 
benefit.
3.5
Drug Metabolism and Pharmacokinetics
Plasma levels of LSALT peptide were measured post-intravenous dosing of 100, 250 and 450 
mg/kg in rats.  Terminal elimination half-lives of  0.66 – 1.17 hr and MRTobs values of 0.58 –
0.85 hr were observed for LSALT peptide.  The AUC0- was linear and close to proportional 
with dose.
LSALT peptide is stable in human plasma for up to 90 minutes with no detectable 
metabolic/proteolytic fragments as measured by mass spectrometry. LSALT peptide is 
undetectable in whole blood in the absence of phosphoric acid due to red or white blood cell 
binding. In human whole blood, 90% or more of the LSALT peptide is contained within the 
cellular compartment. LSALT peptide however is compatible with blood and does not induce 
red blood cell hemolysis. Work is ongoing to identify LSALT peptide volume of distribution, 
tissue biodistribution, and excretion.
3.6
Toxicology and Safety
The maximum tolerated dose (MTD) of LSALT peptide in mice and rats is 100 and 450 mg/kg
respectively, several logs above the minimum effective dose of 100 ng/kg to prevent kidney 
inflammation and injury in mice. In dogs, the MTD of LSALT is 20 mg/kg. In all mouse studies, 
no LSALT peptide-related toxicity has been observed at therapeutic doses.


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3.6.1
14-Day Toxicology Studies
Rats: A GLP study assessed the potential toxicity and toxicokinetics of LSALT peptide 
when administered by intravenous injection to Sprague-Dawley rats once daily for 14 days. 
Three dose groups of 10, 30 and 50 mg/kg were evaluated. The control group was 
administered the vehicle used to prepare the LSALT peptide dosing formulations (0.9% 
sodium chloride, USP).  The LSALT Peptide dose formulations and the control vehicle 
were administered to rats by intravenous bolus injection at a dose volume of 1 mL/kg based 
on the animal’s most recently scheduled body weight. The progression or regression of any 
effects was evaluated during an additional 14-day treatment-free, recovery period in the 
control and high dose groups.
Male and female rats [strain: Crl: CD® (SD) BR-Sprague-Dawley; Charles River] were 
acclimated for this study for 16 days.  During the acclimation period, observations for 
clinical signs and ophthalmology were conducted and body weights as well as food 
consumption were measured.  Following the pre-study evaluations, rats were randomized by 
body weight to control and test groups.   
There were no statistically significant differences in body weight, body weight changes, or 
food consumption between the treated and control groups during the study. 
There were no ophthalmological or neurological findings considered to be related to 
treatment with the test item. 
Changes in hematology and clinical chemistry were mild, generally within normal ranges, 
and unlikely of clinical significance.  
There were no gross findings that could be related to the test item treatment. There were 
no statistically significant findings on organ weights that could be attributed to the test item 
treatment
LSALT Peptide administered to Sprague-Dawley rats by intravenous bolus administration 
daily, for 14 days in the dose range of 10 to 50 mg/kg was well tolerated with no test-item
related effects observed upon evaluation of clinical observations, body weights, food 
consumption, 
clinical 
pathology
(chemistry/hematology), 
gross 
pathology
or 
histopathology. The NOAEL in rats is 50 mg/kg.
Dogs: A GLP study assessed the potential toxicity and toxicokinetics of LSALT Peptide 
when administered by intravenous infusion to Beagle dogs once daily for 14 days.  The 
control group was administered the vehicle used to prepare the LSALT Peptide dosing 
formulations (0.9% sodium chloride, USP).  Three dose groups of 2.5, 7.5 and 15 mg/kg 
were evaluated. The LSALT peptide dose formulation and the control vehicle were 
administered to animals by intravenous infusion at a dose volume of 2 mL/kg based on the 
animal’s most recently scheduled body weight. The progression or regression of any effects 
was evaluated during an additional 14-day treatment-free, recovery period in the control 
and high dose groups.


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LSALT peptide administered to Beagle dogs by intravenous infusion administration daily, 
for 14 days in the dose range of 2.5 to 7.5 mg/kg was well tolerated with no test-item related 
clinical observations noted.  The dose level of 15 mg/kg resulted in manifestation of 
pseudo-allergic (anaphylactoid) reactions1. The clinical signs appeared shortly after dosing 
and consisted of reddening of the skin around the eyes and mouth, head flicking, facial 
edema, hives/reddening on the pinnae, and/or reddened eyes and muzzle. Pseudo-allergic 
reactions were typically observed throughout the entire treatment phase duration.  Affected 
animals were treated with diphenhydramine by IV injection.  These reactions occurred 
during infusion and disappeared shortly after the infusion was completed. Other clinical 
signs were sporadic and were not considered to be related to treatment with the test item.
Thereactions may likely diminish by increasing the time of infusion for delivering dose 
levels more than 15 mg/kg. 
Pseudo-allergic reactions following intravenous administration of peptide/proteins in dogs 
have been reported and occur in response to the infusion of biotherapeutics. Non-clinical 
infusion reactions do not predict responses in humans19-21. .
Repeated dosing in the dose range of 2.5 to 15 mg/kg had no statistically significant effects.
There were no differences in vital signs, body weight, or food consumption between the 
treated and control groups during the study. Changes in hematology and clinical chemistry 
were mild, generally within normal ranges, and unlikely of clinical significance. No 
changes in  gross pathology and histopathology were attributed to the test item. Gross 
findings noted upon necropsy of Main Study animals included a white-tan area of capsular 
thickening and contraction in the spleen of one mid dose female and marked enlargement, 
redness, and protrusion of the right third eyelid in the eye of one high dose female. These 
gross findings were considered incidental and unlikely to be test item related. There were 
no statistically significant findings on organ weights that could be attributed to the test item 
treatment.
The NOAEL in dogs is 2.5 mg/kg.
3.7
Preliminary Safety in Humans
The first 6 cohorts of this study have been completed including subjects receiving a 
single 5 mg dose. No significant adverse effects were reported in any subjects receiving a 
single or multiple doses of the LSALT peptide.
3.8
Study Rationale
Acute kidney injury is a devastating complication for patients undergoing surgery, 
diagnostic imaging or in the context of critical illness. Currently there are no effective 
therapies to prevent or minimize acute kidney injury. Inflammation is an important factor 
1 An allergic reaction is marked by the activation of the immune system by an allergen and includes signs that involve 
the skin, nose/throat, upper airway, GI tract, lungs and cardiovascular system. While the animals exhibited clinical 
features that would be seen in an allergic reaction, given its self-limited nature and severity, and the fact that they
occurred only during the infusion, the findings are considered to represent a non-immune infusion reaction. Thus, the 
effects were considered pseudo-allergic or anaphylactoid.


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in the pathogenesis of acute kidney injury. Given its favorable initial toxicology profile, 
the administration of LSALT peptide to target inflammation and prevent acute kidney 
injury has the potential to provide a significant clinical impact. Since LSALT peptide is a 
new drug, this phase I study to evaluate safety and pharmacokinetics is the first step needed 
to advance the LSALT peptide for the prevention of acute kidney injury in humans.
A third MAD cohort of 5 mg administered intravenously daily for 3 days is being proposed  
to obtain additional pharmacokinetic data.
4.0
OBJECTIVES
4.1 Primary Objective
To determine the safety and tolerability of 4 single and multiple ascending doses of LSALT 
peptide in healthy participants.
4.2 Secondary Objective
To evaluate the pharmacokinetics and pharmacodynamics of LSALT peptide in healthy 
participants
5.0
STUDY DESIGN
This is a double-blind, placebo-controlled, randomized, adaptive design single and multiple 
ascending dose study to evaluate the safety and pharmacokinetics of LSALT peptide in healthy 
participants.
To establish a safe starting dose of LSALT peptide, unblinded low dose escalation will first be 
performed in a small cohort of participants. 0.01 mg of LSALT peptide will be administered 
intravenously (IV) once. If no adverse effects are observed following 72 hours, subsequent single 
(n=1) participants will be administered escalating doses of 0.1 mg, 0.3 mg and 0.5mg every 72 
hours. If no adverse effects are observed at the 0.5 mg dose, then the study will proceed to the first 
cohort of 8 participants (6 active treatment, 2 placebo per dose level) who will receive 1.0 mg of 
LSALT peptide in a double-blinded fashion. Safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) will be assessed before escalating to the next cohort. Dosing will be 
completed in two sequential cohorts of 8 participants using doses of 2.5 mg and 5.0 mg. The first 
2 participants in each blinded cohort will act as sentinels (1 treatment, 1 placebo) who must show 
no adverse effects before continuing the study under the current design. 
Once safety, PK and PD data are completed in the single ascending dose cohort, and the LSALT 
peptide is determined to be safe and well-tolerated by the Safety Review Committee (SRC), the 
multiple ascending dose arm of the study will proceed. The multiple ascending dose arm will 
consist of 2 cohorts of 8 participants receiving 2 independent doses of the LSALT peptide or 
placebo once or twice daily for 3 consecutive days. The doses for this arm of the study will consist 
of the 2 highest doses determined by the SRC to be safe in the SAD cohort. The first cohort will 
receive drug in a double-blinded fashion. Safety, tolerability, PK, and PD will be assessed before 
escalating to the next cohort. Each cohort will consist of 6 active treatment, 2 placebo per dose 


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level. The first 2 participants in each cohort will act as sentinels (1 treatment, 1 placebo) who must 
show no adverse effects before continuing the study under the current design. 
6.0
PATIENT SELECTION
6.1
Inclusion Criteria
1.
Adult participants aged 18-55 years (inclusive at the time of screening).
2.
No prior history of major organ or systemic disease including diabetes, hypertension, 
kidney, heart or liver disease. Participants with childhood asthma are acceptable.
3.
Normal hematology, clinical chemistry and urinalysis parameters at screening, unless 
not deemed clinically significant by the investigator.
4.
Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive)
5.
Taking no prescription medications 2 weeks prior to admission or over-the-counter 
medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up 
to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and 
supplements are permissible at the discretion of the investigator.
6.
Able to allow intravenous medication to be administered.
7.
Males (along with their female partners) and females of childbearing potential (defined 
as a female who is not menopausal or surgically sterilized) must be willing to use an 
acceptable method of birth control during heterosexual activities including a condom 
and a second highly effective method (i.e., hormonal contraceptive, intra-uterine device)
or abstinence for the duration of the study.  Should a woman become pregnant or suspect 
she is pregnant while participating in this study, she must inform her treating physician 
immediately. Males and females should continue with the aforementioned contraception 
for 90 days after the last dose.
8.
Able to understand and willing to sign an ethics committee-approved written informed 
consent document 
9.
Non-smokers. Social and light smokers of up to 10 cigarettes per day who can abstain 
from smoking during the confinement period and have no evidence of underlying lung 
disease (bronchitis, COPD or reactive airways disease).
10. Willing to remain abstinent from alcohol 24 hours prior to admission and until after the 
confinement period in the unit.
6.2
Exclusion Criteria
1.
A history of cardiovascular disease, diabetes or hypertension (Screening assessment 
>150/90 after 5 minutes sitting), significant neurological, pulmonary (including 
asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder.
2.
Prescription medications are prohibited. No prescription medications 2 weeks prior to 
admission or over-the-counter medications 7 days prior to admission. Occasional use of 
paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. 
Routine vitamins and supplements are permissible at the discretion of the investigator
3.
Any moderate or severe allergies, including anaphylaxis, to food, drugs or 
environmental allergens. Mild allergies such as hayfever may be included.
4.
Females who are pregnant or lactating. Women of childbearing potential must have a 
negative pregnancy test within 14 days of study initiation and at baseline.


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5.
Consumption of caffeine 48 hours prior to start of study treatment and whilst confined 
to the unit.
6.
History of any psychiatric illness or psychological disorder which may impair the ability 
to provide written informed consent or participate in the study 
7.
Clinically significant abnormal laboratory value at screening as determined by the 
Investigator.
8.
Participant is sero-positive to HIV-1 or HIV-2, HCV or HBV. 
9.
History or presence of alcoholism within two years prior to the first study drug 
administration or drugs of abuse unless it can be explained to the satisfaction of the 
investigator that it is due to a standard dose of a prescribed medication and that an 
adequate wash-out will occur prior to admission as per inclusion #5
10. No findings on clinical examination that, in the opinion of the investigator, could 
compromise the safety of the participant or the results of the study.
11. Blood donation or significant blood loss within 60 days prior to the first study drug 
administration.
12. Administration of investigational product in another trial within 30 days prior to the first 
study drug administration or five half-lives, whichever is longer.
13. Surgery within the past 3 months prior to the first study drug administration determined 
by the PI to be clinically relevant.
14. Active malignancy or history of malignancy in the past 5 years  
6.3
Enrollment and Randomization
52 participants will be enrolled in the study. 8 participants will be randomly selected to a 
substitution list to be used in the event of drop-out. Block randomization method will be used 
for remaining participants with a sample number of 8/group and a 3:1 treatment:placebo ratio.
A Randomization Plan will be created, and the randomization of eligible study participants will 
be managed as per the plan. A Randomization and Substitution List will be prepared using a 
statistical software package.
6.4 Blinding
Participants and the study investigators/personnel will be blinded. This is a third-party blinded 
study whereupon the pharmacist (or designate) preparing the LSALT peptide or placebo for 
infusion will be unblinded.
6.5 Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this trial.
7.0
STUDY PROCEDURES
This single center study is a double-blind, placebo-controlled, randomized, single and multiple 
ascending dose phase I study of LSALT peptide safety, tolerability, and pharmacokinetics.
7.1 Single Ascending Dose (SAD) Cohort


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7.1.1
Sample Size. The study sample size will be 4 + 24 participants for the SAD arm of 
the protocol. The first 4 participants will comprise a low dose escalation cohort, and 3 cohorts 
of 8 (6 treatment and 2 placebo) will comprise the single ascending dose cohorts. 
7.1.2
LSALT Peptide Dosing. It is anticipated that seven single intravenous doses of 
LSALT peptide (0.01 mg, 0.1 mg, 0.3 mg, 0.5 mg, 1 mg, 2.5 mg and 5 mg) will be 
administered in this arm of the study. 
The first 4 participants will each sequentially receive a single escalating low dose of the 
LSALT peptide (0.01 mg, 0.1 mg, 0.3 mg or 0.5 mg). Escalation to the next dose and 
participant will occur every 72 hours if no adverse effects are seen. Participants will then be 
enrolled in cohorts of 8 and randomized to treatment or placebo in a 3:1 ratio. The dose for 
the first SAD cohort will be 1 mg administered intravenously once over 2 hours. The first 2
subjects of each cohort will be sentinels (1 treatment, 1 placebo). Continuation of the study 
in each cohort will occur if no clinical or biochemical adverse effects are observed in the 
sentinels as determined by the Safety Review Committee (SRC). Escalation to the higher 
dose cohorts (2.5 mg and 5 mg) will occur after 10-14 days if no clinical or biochemical 
adverse effects are observed in the prior cohort.
A rationale for the proposed doses is based on the NOAEL in dogs (2.5 mg/kg) and the 
minimum effective dose in mice (0.1-
). The human equivalent dose is 1.4 mg/kg. 
-fold less than the maximum tolerated 
dose of 20 mg/kg in dogs, 150-fold lower than the NOAEL and provides a safety factor of 
83 relative to the calculated human equivalent dose. The 5 mg dose (83.3 mcg/kg in a 60 kg 
human) is 240-fold less than the maximum tolerated dose of 20 mg/kg in dogs, 30-fold less 
than the NOAEL and provides a safety factor of 17 relative to the calculated human 
equivalent dose. Based on the minimum therapeutic dose observed in mice (0.1 - 1
g/kg),
a conservative first dose of 0.01 mg (166.7 ng/kg in a 60 kg human) is chosen to further 
increase the safety margin of the starting dose by 100-fold (i.e. 8400 x less than the human 
equivalent dose calculated from the NOAEL).
7.1.3
Confinement. Participants will be confined for 24 hours following infusion of the 
LSALT peptide or placebo.
7.1.4
SAD Study Procedures
Day -29. Pretreatment Evaluation and Randomization. 28 days prior to study 
initiation, enrolled participants will undergo informed consent, followed by a complete 
history and physical examination (including body weight and height) including seated 
vital signs (temperature, Blood Pressure, pulse oximetry Respiratory rate and Heart 
Rate), drugs of abuse and an alcohol breath test, baseline fasting laboratory studies 
(CBC, clinical chemistry), Coagulation profile (INR and PTT), urinalysis, 12-lead 
electrocardiogram (Supine) and chest x-ray (Single PA view). Women of child-bearing 
-hCG to rule out pregnancy. Participants will then be randomized.
Low dose cohort
Day -1 Admission. Participant 1 will undergo a clinical evaluation including vital signs, 
complete physical examination
(including body weight and height),
12-lead 


Version: 30Jan2020_V3
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electrocardiogram, drugs of abuse and alcohol breath test, urinalyses, 25 ml of blood 
drawn for safety laboratory investigations including CBC, clinical chemistries,
Coagulation profile (INR and PTT), and women of child-bearing age will have urine 
pregnancy test to rule out pregnancy.
Day 1. First Dose. Participant 1 will undergo a clinical evaluation including vital signs.
Participant 1 receives a single infusion of the LSALT peptide, 0.01 mg administered 
over 2 hours. Clinical evaluation, including vital signs, symptom directed physical 
examination, 12-lead electrocardiogram and 25 ml of blood will be drawn for laboratory 
investigations, including CBC, clinical chemistries and coagulation profile (INR and 
PTT), 24 hours post the end of infusion. If the participant shows no adverse events, they 
will be discharged from the unit on Day 2.
Day 4. Follow up. Participant 1 returns for an outpatient follow up visit. Adverse events 
are recorded, clinical evaluation including vital signs, complete physical examination,
urinalyses, 12-lead electrocardiogram and 25 ml of blood drawn for safety laboratory 
investigations including coagulation profile (INR and PTT),
Day 4. Admission. Participant 2 will undergo a clinical evaluation including vital signs, 
complete physical examination, 12-lead electrocardiogram, drugs of abuse and alcohol 
breath test, urinalysis, 25 ml of blood drawn for safety laboratory investigations
including CBC, clinical chemistries, coagulation profile (INR and PTT) and women of 
child-bearing age will have a urine pregnancy test to rule out pregnancy. 
Day 5. Dose escalation. Participant 2 will undergo a clinical evaluation including vital 
signs. Participant 2 receives a single infusion of the LSALT peptide, 0.1 mg 
administered intravenously over 2 hours. Clinical evaluation, including vital signs,
symptom directed physical examination, 12-lead electrocardiogram ,and 25 ml of blood 
will be drawn for laboratory investigations, including CBC, clinical chemistries and 
coagulation profile (INR and PTT) 24 hours post the end of infusion. If the participant 
shows no adverse events, they will be discharged from the unit on Day 6.
Day 8. Follow up Participant 2 returns for an outpatient follow up visit. Adverse events 
are recorded, clinical evaluation including vital signs, a complete physical examination,
urinalyses, 12-lead electrocardiogram and 25 ml of blood drawn for safety laboratory 
investigations including coagulation profile (INR and PTT).
Day 8 Admission: Participant 3 will undergo a clinical evaluation including vital signs, 
complete physical examination, 12-lead electrocardiogram, drugs of abuse and alcohol 
breath test, urinalyses, 25 ml of blood drawn for safety laboratory investigations
including CBC, clinical chemistries and coagulation profile (INR and PTT) and women 
of child-bearing age will have a urine pregnancy to rule out pregnancy. 
Day 9. Dose escalation. Participant 3 will undergo a clinical evaluation including vital 
signs. Participant 3 receives a single infusion of the LSALT peptide, 0.3 mg 
administered intravenously over 2 hours. Clinical evaluation, including vital signs,
symptom directed physical examination, 12-lead electrocardiogram and 25 ml of blood 
will be drawn for laboratory investigations, including CBC, clinical chemistries and 
coagulation profile (INR and PTT) 24 hours post the end of infusion. If the participant 
shows no adverse events, they will be discharged from the unit on Day 10.
Day 12 Follow up: Participant 3 returns for an outpatient follow up visit. Adverse 
events are recorded, clinical evaluation including vital signs, complete physical 
examination, urinalyses, 12-lead electrocardiogram and 25 ml of blood drawn for safety 
laboratory investigations including coagulation profile (INR and PTT).


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Day 12 Admission: Participant 4 will undergo a clinical evaluation including vital 
signs, complete physical examination, 12-lead electrocardiogram, drugs of abuse and 
alcohol breath test, urinalyses, 25 ml of blood drawn for safety laboratory investigations
including CBC, clinical chemistries, coagulation profile (INR and PTT) and women of 
child-bearing age will have a urine pregnancy test to rule out pregnancy.
Day 13. Dose escalation. Participant 4 will undergo a clinical evaluation including vital 
signs. Participant 4 receives a single infusion of the LSALT peptide, 0.5 mg 
administered intravenously over 2 hours. Clinical evaluation, including vital signs,
symptom directed physical examination, 12-lead electrocardiogram and 25 ml of blood 
will be drawn for laboratory investigations, including CBC, clinical chemistries,
coagulation profile (INR and PTT) 24 hours post the end of infusion. If the participant 
shows no adverse events, they will be discharged from the unit on Day 14
Day 16 Follow up. Participant 4 returns for an outpatient follow up visit. Adverse events 
are recorded, clinical evaluation including vital signs, complete physical examination,
urinalyses, 12-lead electrocardiogram and 25 ml of blood drawn for safety laboratory 
investigations including coagulation profile (INR and PTT).
Treatment and Assessment Timetable (Low Dose)
Note: Fasting for blood sampling required for Screening and post dose Follow up. Participants will be required to have fasted from all 
food and drink except water for at least 8 hours prior to blood sampling .
1. Vital signs dosing day (seated): pre dose (+/-30 mins), 1 hour (+/- 10mins), 2 hour (+/- 10 mins) 6 hours (+/- 15min) and 10 hours 
post completion of infusion (+/- 30 mins).
2. 12 lead electrocardiogram (supine): pre dose (+/- 30 mins), 2 hours (+/- 15 mins) and 8 hours post completion of infusion (+/- 30 
mins)
3. Pregnancy test will be via serum B-hCG at Screening and a urine pregnancy test at pre dose (Study Day -1, Day 4, Day 8, Day 12)
and follow up.
SAD Cohorts
Day -1. Admission to unit; Participants will undergo a clinical evaluation including 
complete vital signs and physical examination, 12-lead electrocardiogram (supine),
drugs of abuse and alcohol breath test, urinalyses and 25 ml of blood drawn for safety 
Participant
1
2
3
4
Study Day
Screening
-29 to -2
-1
1 
2 
4 
4
5
6
8
8
9
10
12
12
13
14
16
In patient period
X
X
X
X
X
X
X
X
Informed 
consent
X
Vital signs
X
X
X1
X
X
X
X1
X
X
X
X1
X
X
X
X1
X
X
Physical Exam
X
X
X
X
X
X
X
X
X
X
X
X
X
Alcohol Breath 
test
X
X
X
X
X
Drugs of Abuse
X
X
X
X
X
Urinalysis
X
X
x
X
X
x
X
X
x
X
X
x
X
CBC
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistry
X
X
X
X
X
X
X
X
X
X
X
X
X
Creatinine/eGFR
X
X
X
X
X
X
X
X
X
X
X
X
X
LFTs
X
X
X
X
X
X
X
X
X
X
X
X
X
INR/PTT
X
X
X
X
X
X
X
X
X
X
X
X
X
CXR
X
ECG
X
X
X2
X
X
X2
X
X
X2
X
X
X2
X
B-hCG3
X
X
X
X
X
X
X
X
X
Adverse Event
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
LSALT 
Administration
X
X
X
X
Discharge from 
unit
X
X
X
X
Follow up
X
X
X
X


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laboratory investigations including CBC, clinical chemistries, coagulation profile (INR 
and PTT) and women of child-bearing age will have a urine pregnancy test to rule out 
pregnancy. 
Day 1. Cohort 1. Participants will undergo a clinical evaluation, including vital signs
and 12-lead electrocardiogram .5 ml of blood will be drawn at 30 prior to LSALT 
peptide infusion for baseline PK measurements. LSALT peptide infusion will begin and 
run over 2 hours. 5 ml of blood will be drawn at 15 minutess, 30 minutes, 1, 2, 4, 6, 8, 
and 12 hours after the LSALT infusion has started.
Day 2. Participants will undergo a clinical evaluation, including vital signs and symptom 
directed physical examination. 25 ml of blood will be drawn for laboratory 
investigations, including CBC, clinical chemistries, coagulation profile (INR and PTT)
and 24 hour PK sample. An ECG will also be completed. If the participant shows no 
adverse events, they will be discharged from the unit.
Day 4. Participants will undergo a clinical evaluation, including vital signs and a
symptom directed physical examination. 25 ml of blood will be drawn for laboratory 
investigations, including 72 hour PK sample. An ECG will also be completed. 
Day 7. Participants will return for a clinical evaluation, including vital signs and a
complete physical examination. 25 ml of blood will be drawn for laboratory 
investigations, including CBC, clinical chemistries and PK. A urinalysis, CXR and ECG 
will also be completed. Women of child-bearing age will have a urine pregnancy test to 
rule out pregnancy
Day 14. Cohort 2. Conducted as per Cohort 1 to day 7.
Day 28. Cohort 3. Conducted as per Cohort 1 to day 7.
Treatment and Assessment Timetable (SAD)
Study Day
Screen 
-29 to -2
-1
1
2
4
7
In patient period
X
X
Informed consent
X
Vital signs
X
X
X4
X
X
X
Physical Exam
X
X
X
X
X
Alcohol Breath Test
X
X
Drugs of Abuse6
X
X
Urinalysis
X
X
x
X
CBC
X
X
X
X
Chemistry
X
X
X
X
Creatine/eGFR
X
X
X
X
LFTs
X
X
X
X
PK
X1
X2
X3
X
INR/PTT
X
X
CXR
X
X
ECG
X
X
X5
X
X
X
B-hCG7
X
X
X
Adverse Event
X
X
X
X
X
X
LSALT Administration
X
Discharge from unit
X
Follow up
X
X
Note: Fasting for blood sampling required for Screening and post dose Follow up. Participants will be required to have fasted from all 
food and drink except water for at least 8 hours prior to blood sampling.
1.
PK blood samples: 5 ml of blood will be drawn at 30 mins pre (+/- 5 mins) and 15 mins (+/- 5 mins), 30 mins (+/- 5 mins), 45 mins
(+/- 5 mins), 1h (+/- 5 mins), 2h (+/- 5 mins), 4h (+/- 10 mins), 6h (+/- 10 mins), 8h (+/- 10 mins), and 12h (+/- 30 mins) after the 
LSALT infusion has completed
2.
PK blood sample: 24 hours (+/- 30 mins) after infusion has completed
3.
PK blood sample: 72 hours (+/- 30 mins) after Infusion has completed


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4.
Vital signs dosing day (seated): pre dose within 30 mins prior to infusion start), 1 hour (+/- 10mins), 2 hour (+/- 10 mins) 6 hours (+/-
15min) and 10 hours post completion of infusion (+/- 30 mins)
5.
12 lead electrocardiogram (supine): pre dose (+/- 30 mins), 2 hours (+/- 15 mins) and 8 hours post completion of infusion (+/- 30 
mins)
6.
Repeat Drugs of Abuse (DoA) is permitted at the discretion of the Investigator
7.
Pregnancy test will be via serum B-hCG at Screening and a urine pregnancy test at pre dose (Study Day -1Day 12) and follow up 
7.2 Multiple Ascending Dose (MAD) Cohort
7.2.1
Sample Size. The study sample size will be 24 for the MAD arm of the protocol in 
cohorts of 8. Participants will be randomized to treatment or placebo in a 3:1 ratio. The first 
2 subjects of each cohort will be sentinels (1 treatment, 1 placebo). Continuation of the study 
in each cohort will occur if no clinical or biochemical adverse effects are observed in the 
sentinels as determined by the Safety Review Committee (SRC). Escalation to the higher 
dose will occur if no clinical or biochemical adverse effects are observed after a 10 day 
follow-up period as determined by the SRC.
7.2.2
LSALT Peptide Dosing. The doses for the MAD cohorts will be determined by 
the SRC based on the results from the prior SAD and MAD arms of the study. These doses 
have been determined to be 1 mg, 2.5 mg and 5 mg. LSALT peptide will administered 
intravenously once daily for 3 days. The starting dose for the Phase 1 clinical study will be 
subject to change and reassessed based on the results from the SAD cohort and in accordance 
with FDAs guidance document for estimating a safe starting dose in initial clinical trials.
7.2.3
Confinement. Participants will be confined for days -1 to day 4 during the 
administration of the LASLT peptide.
7.2.4
Replacement. In the event of participant drop-out, participants from the reserve 
pool will be enrolled in the study and randomized.
7.2.5
MAD Study Procedures
Day -29. Pretreatment Evaluation and Randomization. 29 days prior to study 
initiation, enrolled participants will undergo informed consent, followed by a complete 
history and physical examination (including body weight and height) vital signs
(seated), alcohol breath test, drugs of abuse test, baseline fasting laboratory studies 
(CBC, clinical chemistry) including coagulation profile (INR and PTT),  urinalysis, 12-
lead, electrocardiogram (supine) and chest x-ray (single PA view). Women of child-
-hCG to rule out pregnancy. Participants will then be 
randomized.
Day -1. Admission to unit. Participants will undergo a clinical evaluation including 
complete vital signs and physical examination, 12-lead electrocardiogram (supine),
drugs of abuse and alcohol breath test, urinalyses, 25 ml of blood drawn for safety 
laboratory investigations including CBC, clinical chemistries, urinalysis and women of 
child-bearing age will have a urine pregnancy test to rule out pregnancy. 
Day 1. Participants will undergo clinical evaluation including vital signs. 5 ml of blood 
will be drawn at 30 minutes prior to LSALT peptide infusion for baseline PK 
measurements. LSALT peptide infusion will begin and run over 2 hours. 5 ml of blood 
will be drawn at 15, 30, 45 60, 75, 90, 105, 120, 125, 130, 135, 140 minutes, and 3 hours 
from the onset of the LSALT infusion.


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Day 2. Participants will undergo a clinical evaluation, including vital signs, a brief 
history and symptom directed physical exam. 25 ml of blood will be drawn for 
laboratory investigations, including CBC, clinical chemistries and coagulation profile 
(INR and PTT), urinalysis and 24 hour PK sample (from the onset of the first LSALT 
infusion). An ECG will also be completed. If the participant shows no adverse events, 
they will receive the second dose of the LSALT peptide.
Day 3. Participants will undergo a clinical evaluation, including vital signs, a brief 
history and a symptom directed physical exam. If the participant shows no adverse 
events, they will receive the third dose of the LSALT peptide. 5 ml of blood will be 
drawn at 15, 30, 45 60, 75, 90, 105, 120, 125, 130, 135, 140 minutes, and 3 hours from 
the onset of the LSALT infusion.
Day 4. Participants will undergo a clinical evaluation, including vital signs and a
symptom directed physical examination. 25 ml of blood will be drawn for laboratory 
investigations, including CBC, clinical chemistries, coagulation profile (INR and PTT)
and a 72 hour PK sample (from the onset of the first LSALT infusion). A urinalysis, 
CXR and ECG will also be completed. If the participant shows no adverse events, they 
will be discharged from the unit.
Day 7. Participants will return for a clinical evaluation, including a brief history, vital 
signs and a symptom directed physical examination. 25 ml of blood will be drawn for 
laboratory investigations, including CBC, clinical chemistries, coagulation profile (INR 
and PTT) and a 96 hour PK sample (from the end of the 3rd LSALT infusion). A 
urinalysis will also be completed.
Day 14. Participants will return for a clinical evaluation, including a brief history, vital 
signs and symptom directed physical examination. 25 ml of blood will be drawn for 
laboratory investigations, including CBC, clinical chemistries. A urinalysis will also be 
completed and a sample of blood drawn for anti-drug antibodies.
Day 21. Participants will return for a clinical evaluation, including a brief history, vital 
signs and a complete physical examination. 25 ml of blood will be drawn for laboratory 
investigations, including CBC, clinical chemistries. A urinalysis and ECG will also be 
completed. Women of child-bearing age will also have a urine pregnancy test
Day 28. Begin Cohort 2 or 3. Conducted as per Cohort 1 to day 21.
Treatment and Assessment Timetable (MAD)
Study Day
Screen
-29 to -2
-1
1
2
3
4
7
14
21
In patient period
X
X
X
X
Informed consent
X
Vital signs
X
X
X6
X6
X6
X
X
X
X
Physical Examination
X
X
X
X
X
X
X
X
Alcohol Breath Test
X
X
Drugs of Abuse
X
X
Urinalysis
X
X
X
X
X
X
X
CBC
X
X
X
X
X
X
X
Chemistry
X
X
X
X
X
X
X
Creatinine/eGFR
X
X
X
X
X
X
X
LFTs
X
X
X
X
X
X
X
PK
X1
X2
X3
X4
X5
INR/PTT
X
X
X
X
CXR
X
X
ECG
X
X
X7
X7
X7
X
X


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B-hCG8
X
X
X
Adverse Event
X
X
X
X
X
X
X
X
Anti-Drug Antibodies
X
LSALT Administration
X
X
X
Discharge from unit
X
Follow up
X
X
X
Note: Fasting for blood sampling required for Screening and post dose Follow up. Participants will be required to have 
fasted from all food and drink except water for at least 8 hours prior to blood sampling.
1.
PK blood samples: 5 ml of blood will be drawn at 30 prior to LSALT peptide infusion for baseline PK measurements. LSALT peptide 
infusion will begin and run over 2 hours. 5 ml of blood will be drawn at 15, 30, 45 60, 75, 90, 105, 120, 125, 130, 135, 140 (+/- 2 min)
minutes, 3 hours (+/- 5 min) from the onset of the LSALT infusion
2.
PK blood sample: 24 hours (+/- 30 mins) from the onset of the 1st infusion.
3.
PK blood samples: 5 ml of blood will be drawn at 30 prior to LSALT peptide infusion. LSALT peptide infusion will begin and run 
over 2 hours. 5 ml of blood will be drawn at 15, 30, 45 60, 75, 90, 105, 120, 125, 130, 135, 140 (+/- 2 min) minutes and 3 hours (+/- 5 
min) from the onset of the LSALT infusion
4.
PK blood sample: 72 hours (+/- 30 mins) from the onset of the first LSALT infusion
5.
PK blood sample: 96 hours (+/- 30 mins) from the end of the third LSALT infusion
6.
Vital signs dosing day (seated): pre dose (+/-30 mins), 1 hour (+/- 10mins)
, 2 hour (+/- 10 mins) 6 hours (+/- 15min) and 10 hours 
post completion of infusion (+/- 30 mins)
7.
12 lead electrocardiogram (supine): pre dose (+/- 30 mins), 2 hours (+/- 15 mins) and 8 hours post completion of infusion (+/- 30 
mins)
8.
Pregnancy test will be via serum B-hCG at Screening and a urine pregnancy test at pre dose (Study Day -1,) and follow up 
7.3
Investigational Drug Product, Monitoring and Safety Procedures
7.3.1
Investigational Drug Product. The investigational drug product (LSALT peptide)
will be supplied to the study site in aqueous solution at -20°C as a single concentration (1
mg/ml) in a glass vial with restricted access to the site pharmacist or designate. All four
doses will be derived from the same formulation prior to patient administration. LSALT 
peptide vials will be single use only. Drug receipt/administration logs and temperature logs 
will be maintained by the study site using the Drug Accountability Form.
The 
pharmacist/designate will ensure that the total number of vials in the drug dispatch log is 
present in the shipment from the sponsor. The pharmacist/designate will also ensure that 
there is no evidence of breakage of the drug vials. The CRO or sponsor must be notified 
immediately if any discrepancy is identified in the drug or temperature log or if any breakage 
occurs.
The LSALT peptide vial will be labeled in English and according to local regulatory 
requirements. The pharmacist or designate will be unblinded. 
7.3.2
Drug Administration. LSALT peptide or an equivalent volume of 0.9% sodium 
chloride will be diluted in 0.9% sodium chloride solution to a volume of 100 ml mini-IV bag 
by an unblinded pharmacist or designate. The drug will be infused into the patient through a 
peripheral 18, 20 or 22 g intravenous catheter over 2 hours and under the supervision of the 
study investigator.
7.3.3
Pharmacy records. The principal investigator or a designate will be responsible 
for ensuring that the study site maintains an accurate record of the LSALT peptide inventory 
using the Drug Accountability Form. A coded label will be affixed to the patient CRF to 
identify placebo and LSALT peptide treated subjects.
7.3.4
Pretreatment Evaluation. 28 days prior to study initiation, enrolled participants
will have a complete history and physical examination including vital signs, baseline fasting 


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laboratory studies (CBC, clinical chemistry), urinalysis, 12-lead electrocardiogram and chest 
x-ray (single PA view).
7.3.5
Safety Assessment. Patients will be monitored during drug administration and up
to 3 weeks thereafter. Patients will be monitored for adverse effects using vital signs (seated, 
respiratory rate, heart rate, blood pressure, temperature and pulse oximetry), hematology,
clinical chemistry, seated, supine single 12-lead electrocardiograms, chest radiography, and 
urine testing. Adverse events during the study will be reported and graded as per the CTCAE 
version 5.0.
7.3.6
Laboratory Testing. 25 mL of blood will be drawn for fasting laboratory 
assessment (hematology and clinical chemistries) at screening, baseline (pre-dose Day 1),
and on study days 2, 4, and 7 (refer to Flow Chart). Additional bloodwork will be drawn at 
day 14 in the MAD cohort. In addition, 5 mL of blood will be collected for pharmacokinetic 
analysis at 30-minutes pre-dose, then 15, 30, 45 60, 75, 90, 105, 120, 125, 130, 135, 140 
minutes, and 3 hours from the onset of the LSALT infusion, 24 hours post drug 
administration on day 2 (from onset of 1st LSALT dose, SAD and MAD cohort), 72 hours 
post drug administration on day 4 (from onset of 1st LSALT dose, SAD and MAD cohort),
and 96 hours post drug administration on day 7 (from onset of 3rd LSALT dose, MAD cohort).
Participants will be required to have fasted from all food and drink except water for at least 
8 hours prior to blood sampling.
Baseline hematology will include hemoglobin, hematocrit, total white blood cell count, 
white blood cell differentiation and platelet count. INR and PTT will also be performed. 
Clinical chemistry (fasting state) will include total protein, albumin, sodium, potassium, 
chloride, bicarbonate, random glucose, insulin, calcium, magnesium, phosphate, urea, uric 
acid, AST, ALT, ALP, LDH, TBili, GGT, creatinine, triglycerides, total cholesterol, and 
urinalysis (dipstick for protein, blood, glucose, ketones, pH, leukocytes and microscopic 
examination only if dipstick is not completely negative). Urinalysis will be conducted at the 
same times as the blood draws for hematology and clinical chemistries.
7.3.7
Women of Childbearing Potential. Women of childbearing potential (defined as 
women with regular menses, women with amenorrhea, women with irregular cycles, women 
using a contraceptive method that precludes withdrawal bleeding,) are required to have a 
negative serum pregnancy test
-HCG) during screening and at the end of the study 
treatment.  
Female and male participants (along with their female partners) are required to use a method 
of acceptable contraception, including one barrier method (condom) and one additional
highly effective method (i.e., hormonal contraceptive, intra-uterine device) or abstinence for 
the duration of the study for 90 days following the last dose of study drug.
7.3.8
Duration of Follow-up. Participants are evaluated for adverse events for 72 hours 
and 6 days after receiving the low dose and single dose of study drug respectively. Patients 
receiving multiple daily dosing are evaluated for 17 days after receiving the last dose of the 
LSALT peptide. Participants with adverse events will be followed until resolution or 
stabilization of the adverse event. Follow-up after the conclusion of the study participation
will be per routine clinical care.


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8.0
DOSE ESCALATION AND STOPPING RULES
The first 4 participants will each receive a single low ascending dose of the LSALT peptide. 
Escalation of the dose in the next participant will occur at 72 hours if the prior participant 
experienced no adverse effects. The SRC will convene 24 hours after dosing of the last participant 
to determine if any changes in protocol design or SAD dosing are required. 96 hours following
completion of this first low dose escalation phase, in the absence of adverse effects, participants
in cohorts of 8 will be randomized 3:1 to receive the LSALT peptide or placebo. The dose for the 
first SAD cohort will be one intravenous infusion of 1.0 mg of LSALT peptide. The first 2 patients 
in each SAD cohort will be sentinels (1 treatment and 1 placebo). The SRC will convene 24 hours 
after dosing of the last sentinel patient to determine if any changes in protocol design or dosing 
are required. Sequential single dosing of LSALT peptide will occur as planned if sentinel 
participants show no clinical, biochemical or hematologic abnormalities. The SRC will convene 
72 hours after dosing of the last participant to determine continuation of the single dose arm and 
next ascending dose cohort.
7 days following the completion of the SAD study arm, the SRC will convene to determine 
transition to the MAD study arm, the starting LSALT peptide dose and frequency. Entry into the 
multiple ascending dose arm will occur if no clinical, biochemical or hematologic abnormalities 
are observed at the SAD cohorts after 7 days. The starting dose of the MAD will consist of the 3
highest doses that caused no adverse effects in the SAD cohorts.
One adverse event (grade 3 or greater) in a participant or 2 moderate adverse events (grade 2) in 
the same cohort will result in a study pause and re-evaluation of the protocol. Termination of the
trial will occur if 2 or more grade 3 or greater adverse events occur in the same cohort.
9.0
REGULATORY AND REPORTING REQUIREMENTS
9.1
Adverse Events (AEs)
Definition: Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment.
9.2
Severity (Intensity)
The descriptions and grading scales found in the revised NCI Common Terminology Criteria 
for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.  A copy of 
the CTCAE version 5.0 can be downloaded from the CTEP website. Severity of AEs will be 
assessed as follows:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.  
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age
appropriate instrumental activities of daily living.
Grade 3 Severe; Medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.


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Grade 4 Life-threatening consequences; urgent intervention indicated. 
9.3
Assessment of Causality
All AEs (both serious and nonserious) will be assessed for relationship to investigational 
product by the Investigator. The investigator will assess the relationship of AEs to 
investigational product administration using the following categories:
Unrelated: The AE is clearly not related to the LSALT peptide and is clearly related to an 
underlying disease, environmental or toxic factor(s), or other drug/therapy.
Unlikely related: The AE does not follow a reasonable temporal sequence after LSALT peptide
administration (eg, too soon or too long after investigational product or investigational product 
was not taken) and is plausibly related to an underlying disease, environmental or toxic 
factor(s), or other drug/therapy. For purposes of regulatory reporting, AEs classified as unlikely
related will be considered unrelated to the LSALT peptide.
Possibly related: The AE follows a reasonable temporal sequence after investigational product 
administration but may be related to an underlying disease, environmental or toxic factor(s), or 
other drug/therapy. There is a reasonable possibility of a causal relationship between 
investigational product administration and the AE. For purposes of regulatory reporting, AEs 
classified as possibly related will be considered related to investigational product.
Probably related: The AE follows a reasonable temporal sequence after LSALT peptide
administration and is unlikely to be related to an underlying disease, environmental or toxic 
factor(s), or other drug/therapy. The AE is consistent with the known response pattern of the 
LSALT peptide and may respond to stopping the LSALT peptide. For purposes of regulatory 
reporting, AEs classified as probably related will be considered related to the LSALT peptide.
Related: The adverse event is clearly related to the LSALT peptide; a re-challenge confirms 
the association (not required or desirable in some circumstances but provides strong evidence 
when it happens).
9.4
Expectedness
An unexpected adverse drug experience is defined as any adverse effect related to the 
investigational drug product, the specificity or severity of which is not consistent with the 
current investigator brochure (or risk information, if an IB is not required or available).
9.5
Serious Adverse Events (SAEs)
Each AE must be assessed and recorded in the eCRF as serious or not serious. Serious AEs 
must be reported as described in Section 7.9. International Conference on Harmonization 
Guidelines and the Code of Federal Regulations (CFR; 21 CFR 312.32, revised as of 01 April 
2017). An SAE is defined as any adverse drug experience occurring at any dose that results in 
any of the following outcomes:
Death;
*A life-threatening adverse event;
Inpatient hospitalization for at least 24 hours or prolongation of existing hospitalization;


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A persistent or significant disability/incapacity (i.e. substantial disruption of the ability to 
conduct normal life functions); or
A congenital anomaly/birth defect.
Medical and scientific judgement should be exercised in deciding whether expedited reporting 
is appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalisation but may jeopardise the patient or may 
require intervention to prevent one of the other outcomes listed in the definition above. These 
should also usually be considered serious.
*A life-threatening adverse event is defined as any adverse drug experience that places the 
participant (in the view of the investigator) at immediate risk of death from the reaction as it 
occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might 
have caused death.
9.6
Pregnancy
Should a female participant become pregnant or suspect she is pregnant while participating in 
this study, or should a male patient’s partner become pregnant or suspect she is pregnant while 
the male is participating in this study, the treating investigator should be informed immediately. 
Female patients will be withdrawn from the study, and all pregnancies will be reported along 
the same timelines as a SAE. The Human Research Ethics Committee (HREC) and the sponsor 
will be informed. The participant will be asked to provide information on the outcome of the 
pregnancy, including premature termination should the case arise.
Spontaneous miscarriage and congenital abnormalities will be reported as SAEs. The follow-
up period will be deemed to have ended when the health status of the child has been determined 
on its birth and followed up for 8 weeks following the birth for any potential abnormalities.
9.7
Reporting of Serious Adverse Effects
The Study Site PI, or delegate is required to promptly notify the Sponsor of the following 
events:
Any unanticipated problems including serious adverse events involving risks to 
participants or others which occur at the study site, or that impacts participants or the 
conduct of the study.
Noncompliance with federal regulations or the requirements or determinations of the 
Sponsor.
Receipt of new information that may impact the willingness of participants to 
participate or continue participation in the research study.
Any SAE must be reported by the investigator if it occurs during the clinical study or within 1 day of 
receiving the LSALT peptide, whether or not the SAE is considered to be related to the LSALT 
peptide. An SAE report consists of the SAE report form, and where applicable the concomitant
medication/history form. A copy of these forms must be emailed or faxed within 24 hours for the 
attention of the Sponsor’s safety representative:


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Attention Syneos Health Safety & Pharmacovigilance
Email: safetyreporting@syneoshealth.com (preferred)
Local Toll-Free Fax (Australia): 1 800 256 952
Alternate (Global) Fax: +1 877 464 7787
The investigator should not wait to receive additional information to document fully the event 
before notification of a SAE, though additional information may be requested. Where 
applicable, information from relevant laboratory results, hospital case records, and autopsy 
reports should be obtained and provided upon request.
9.8
Protocol Exceptions
A planned deviation from the approved protocol that are under the research team’s control must 
be approved by the sponsor and ethics committee. Waivers are not acceptable.
9.9
Unblinding
Adverse events Grade 2 or greater will trigger unblinding to allow study personnel and the PI 
to best manage the study participant and clinical situation.
10.0
PHARMACEUTICAL INFORMATION
10.1 LSALT Peptide
10.1.1 LSALT Peptide Description.
LSALT is an unmodified peptide with the molecular formula: Leu-Ser-Ala-Leu-Thr-Pro-
Ser-Pro-Ser-Trp-Leu-Lys-Tyr-Lys-Ala-Leu
Molecular weight: 1775 Da
10.1.2
Mechanism of Action
LSALT peptide is a non-enzymatic inhibitor of dipeptidase-1
10.1.3
Manufacturer
CS Bio Co.
20 Kelly Court
Menlo Park, CA 
94025 USA
10.1.4
Dosage
Supplied as 1 mg/ml solution in 5 ml 0.9% sodium chloride. Dosages for this study are 0.01 mg, 
0.1 mg, 0.3 mg, 0.5 mg, 1.0 mg, 2.5 mg and 5 mg.


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10.1.5
Storage
LSALT peptide in 0.9% sodium chloride is stored at -20° C and thawed immediately before 
use as per pharmacy manual.
10.1.6
Administration
LSALT peptide is diluted in 100 ml of 0.9% sodium chloride and administered intravenously
over 2 hours ± 5 minutes. Based upon evaluation of tolerability and safety of the first cohort, 
and consistent with the adaptive design, infusion rates could be increased or decreased for 
subsequent cohorts, as determined by the SRC.
11.0
MONITORING AND QUALITY
Data for each subject will be recorded on an eCRF. Data collection must be completed for each 
subject who signs an informed consent form (ICF) and is administered study drug. In accordance 
with cGCP and ICH guidelines, the study monitor will carry out source document verification at 
regular intervals to ensure that the data collected in the CRF are accurate and reliable. The 
investigator must permit the monitor, the IEC/IRB, the sponsor’s internal auditors, and 
representatives from regulatory authority’s direct access to all study-related documents and 
pertinent hospital or medical records for confirmation of data contained within the CRFs.
12.0
AUDIT AND INSPECTION
Study sites and study documentation may be subject to Quality Assurance audit during the course 
of the study by the sponsor or its nominated representative. In addition, inspections may be 
conducted by regulatory authorities at their discretion.
13.0 ETHICS, REGULATORY, INFORMED CONSENT AND PATIENT 
CONFIDENTIALITY 
13.1
Independent Ethics Committee or Institutional Review Board
Before initiation of the study at each study center the protocol, the ICF, other written material 
given to the participants, and any other relevant study documentation will be submitted to the 
appropriate IEC/IRB. Written approval of the study and all relevant study information must 
be obtained before the study center can be initiated or the study drug is released to the 
investigator. Any necessary extensions or renewals of IEC/IRB approval must be obtained for 
changes to the study such as amendments to the protocol, the ICF or other study 
documentation. The written approval of the IEC/IRB together with the approved ICF must be 
filed in the study files.
The investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the participants or the conduct of the study. The investigator will submit 
written summaries of the study status to the IEC/IRB as required. On completion of the study, 
the IEC/IRB will be notified that the study has ended.
13.2
Regulatory Authorities


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Relevant study documentation will be submitted to the regulatory authorities of the 
participating country, according to local/national requirements, for review and approval 
before the beginning of the study. On completion of the study, the regulatory authorities will 
be notified that the study has ended.
13.3
Ethical Conduct of the Study
The investigator(s) and all parties involved in this study should conduct the study in adherence 
to the ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines, and the 
applicable national and local laws and regulatory requirements.
13.4
Informed Consent
The process of obtaining informed consent must be in accordance with applicable regulatory 
requirement(s) and must adhere to GCP.
The investigator is responsible for ensuring that no participant undergoes any study related 
examination or activity before that subject has given written informed consent to participate 
in the study.
The investigator or designated personnel will inform the participant of the objectives, 
methods, anticipated benefits and potential risks and inconveniences of the study. The 
participant should be given every opportunity to ask for clarification of any points s/he does 
not understand and, if necessary, ask for more information. At the end of the interview, the 
participant will be given ample time to consider the study. Participants will be required to sign 
and date the ICF. After signatures are obtained, the ICF will be kept and archived by the 
investigator in the investigator’s study file. A signed and dated copy of the subject ICF will 
be provided to the participant or their authorized representative.
It should be emphasized that the participant may refuse to enter the study or to withdraw from 
the study at any time, without consequences for their further care or penalty or loss of benefits 
to which the participant is otherwise entitled. Subjects who refuse to give or who withdraw 
written informed consent should not be included or continue in the study.
If new information becomes available that may be relevant to the participant’s willingness to 
continue participation in the study, a new ICF will be approved by the IEC(s)/IRB(s) (and 
regulatory authorities, if required). The study participants will be informed about this new 
information and reconsent will be obtained.
13.5
Subject Confidentiality
Monitors, auditors, and other authorized agents of the sponsor and/or its designee, the 
IEC(s)/IRB(s) approving this research, and the Australian Therapeutic Goods Administration 
(TGA), as well as that of any other applicable agency(ies), will be granted direct access to the 
study participants’ original medical records for verification of clinical study procedures and/or 
data, without violating the confidentiality of the participants to the extent permitted by the law 


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and regulations. In any presentations of the results of this study or in publications, the 
participants’ identity will remain confidential.
14.0
DATA AND SAFETY MONITORING
The study principal investigator and Research Patient Coordinator will monitor for serious 
toxicities on an ongoing basis. Once the principal investigator or Research Patient Coordinator 
becomes aware of an adverse event, the AE will be reported to the Sponsor.
15.0
PHARMACOKINETIC STUDIES
Blood samples will be drawn from participants for pharmacokinetic analysis at 15- and 30-
minutes pre-dose and then 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post drug administration on day 1 
(SAD and MAD cohort) and day 3 (MAD cohort).
Pharmacokinetic analysis will be performed using validated analytic method.
16.0
STATISTICAL ANALYSIS
Demographics and baseline characteristics will be tabulated and summarized by SAD/MAD dose 
level. Physical examination and medical/surgical history data will be listed by participant.
All clinical safety and tolerability data will be listed for each participant and summarized by dose. 
Vital signs and ECG parameters will be tabulated and summarized by SAD/MAD dose level. 
Laboratory values will be listed, along with comments as to clinical significance for values outside 
the laboratory’s normal ranges.
Treatment-emergent adverse events, following the investigational product dosing, will be listed 
and summarized by dose level. All adverse events reported in this study will be coded using 
MedDRA.
Individual plasma concentrations and blood collection times will be listed by participant.
Summaries of concentration data will include mean, standard deviation and coefficient of variation 
by SAD/MAD dose level at each scheduled collection time. Summaries of PK parameters by 
SAD/MAD dose level will include mean, SD and CV.
17.0
RECORD RETENTION
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced. After completion of the study (end of study defined as 
the date of the last visit of the last participant), all documents and data relating to the study will be 
kept in an orderly manner by the investigator in a secure study file. This file will be available for 
inspection by the sponsor or its representatives. Essential documents should be retained for 2 years 
after the final marketing approval in an ICH region or for at least 2 years since the discontinuation 
of clinical development of the investigational product. It is the responsibility of the sponsor to 
inform the study center when these documents no longer need to be retained. The investigator must 
contact the sponsor before destroying any study related documentation. In addition, all participant


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medical records and other source documentation will be kept for the maximum time permitted by 
the hospital, institution, or medical practice.
The sponsor must review and approve any results of the study or abstracts for professional 
meetings prepared by the investigator(s). Published data must not compromise the objectives of 
the study. 


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18.0
SCHEMA


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19.0
REFERENCES
REFERENCES
1.
Kopf, M., Bachmann, M.F. & Marsland, B.J. Averting inflammation by targeting the 
cytokine environment. Nat Rev Drug Discov 9, 703-718 (2010).
2.
Nourshargh, S. & Alon, R. Leukocyte migration into inflamed tissues. Immunity 41, 694-
707 (2014).
3.
Takeuchi, O. & Akira, S. Pattern recognition receptors and inflammation. Cell 140, 805-
820 (2010).
4.
Kuchroo, V.K., Ohashi, P.S., Sartor, R.B. & Vinuesa, C.G. Dysregulation of immune 
homeostasis in autoimmune diseases. Nat Med 18, 42-47 (2012).
5.
Chawla, L.S., Eggers, P.W., Star, R.A. & Kimmel, P.L. Acute kidney injury and chronic 
kidney disease as interconnected syndromes. N Engl J Med 371, 58-66 (2014).
6.
Rosner, M.H. & Okusa, M.D. Acute kidney injury associated with cardiac surgery. Clin J 
Am Soc Nephrol 1, 19-32 (2006).
7.
Alobaidi, R., Basu, R.K., Goldstein, S.L. & Bagshaw, S.M. Sepsis-associated acute 
kidney injury. Semin Nephrol 35, 2-11 (2015).
8.
Angus, D.C. & van der Poll, T. Severe sepsis and septic shock. N Engl J Med 369, 2063 
(2013).
9.
Kempker, J.A. & Martin, G.S. The Changing Epidemiology and Definitions of Sepsis. 
Clin Chest Med 37, 165-179 (2016).
10.
Nesseler, N., et al. Clinical review: The liver in sepsis. Crit Care 16, 235 (2012).
11.
Kim, W.Y. & Hong, S.B. Sepsis and Acute Respiratory Distress Syndrome: Recent 
Update. Tuberc Respir Dis (Seoul) 79, 53-57 (2016).
12.
Salvadori, M., Rosso, G. & Bertoni, E. Update on ischemia-reperfusion injury in kidney 
transplantation: Pathogenesis and treatment. World J Transplant 5, 52-67 (2015).
13.
Gaber, A.O., et al. YSPSL (rPSGL-Ig) for improvement of early renal allograft function: 
a double-blind, placebo-controlled, multi-center Phase IIa study. Clin Transplant 25, 523-
533 (2011).
14.
James, M.T., et al. Associations between acute kidney injury and cardiovascular and 
renal outcomes after coronary angiography. Circulation 123, 409-416 (2011).
15.
James, M.T., et al. Acute kidney injury following coronary angiography is associated 
with a long-term decline in kidney function. Kidney Int 78, 803-809 (2010).
16.
Rear, R., Bell, R.M. & Hausenloy, D.J. Contrast-induced nephropathy following 
angiography and cardiac interventions. Heart 102, 638-648 (2016).
17.
Rajotte, D. & Ruoslahti, E. Membrane dipeptidase is the receptor for a lung-targeting 
peptide identified by in vivo phage display. J Biol Chem 274, 11593-11598 (1999).
18.
Heywood, S.P. & Hooper, N.M. Development and application of a fluorometric assay for 
mammalian membrane dipeptidase. Anal Biochem 226, 10-14 (1995).
19.
Mease, K.M., Kimzey, A.L. & Lansita, J.A. Biomarkers for nonclinical infusion reactions 
in marketed biotherapeutics and considerations for study design. Curr Opin Toxicol 4, 1-
15 (2017).
20.
Cohn, L.A., Kerl, M.E., Lenox, C.E., Livingston, R.S. & Dodam, J.R. Response of 
healthy dogs to infusions of human serum albumin. Am J Vet Res 68, 657-663 (2007).
21.
Rosello, S., et al. Management of infusion reactions to systemic anticancer therapy: 
ESMO Clinical Practice Guidelines. Ann Oncol 28, iv100-iv118 (2017).


Version: 30Jan2020_V3
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Statistical Analysis Plan for Interventional Studies
Sponsor Name: Arch Biopartners Inc.
Protocol Title: A phase I double-blind, placebo-controlled, randomized, single and multiple ascending
dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in
healthy participants
Protocol Number: AB001
Protocol Version and Date: V3, 30-Jan-2020
Syneos Health Project Code: 7001012
Author: Konstantine Dres, Biostatistician II 
Notice of Confidential and Proprietary Information:
The information contained in this document is confidential belonging to Arch Biopartners Inc. Acceptance 
of this document constitutes agreement by the recipient that no information contained herein will be 
published or disclosed without prior written authorization from an official of Arch Biopartners Inc. 
However, this document may be disclosed to appropriate Institutional Review Board and Ethics 
Committees or duly authorized representatives of a national regulatory authority under the condition that 
they are requested to keep it confidential. In the event of an actual or suspected breach of this obligation, 
Syneos Health should be notified promptly.


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Revision History
Version #
Date
(DD-Mmm-YYYY)
Document Owner
Revision Summary
v1.0 
22-Dec-2019 
Konstantine Dres
v2.0
2-Apr-2020
Konstantine Dres
Additional Cohort added to the MAD portion




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Table of Contents
Revision History.......................................................................................................................... 2 
Approvals .................................................................................................................................. 3 
 
Glossary of Abbreviations................................................................................................... 6 
1.
 
Purpose.............................................................................................................................. 7 
2.
2.1. 
Responsibilities...................................................................................................... 7 
2.2. 
Timings of Analyses............................................................................................... 7 
 
Study Objectives ................................................................................................................ 8 
3.
3.1. 
Primary Objective .................................................................................................. 8 
3.2. 
Secondary Objective.............................................................................................. 8 
3.3. 
Brief Description .................................................................................................... 8 
3.4. 
Subject Selection................................................................................................... 8 
3.5. 
Determination of Sample Size................................................................................ 8 
3.6. 
Treatment Assignment........................................................................................... 9 
3.7. 
Randomization and Blinding .................................................................................. 9 
 
Endpoints .........................................................................................................................11 
4.
4.1. 
Safety Endpoints (Primary) ...................................................................................11 
4.2. 
Pharmacokinetic Endpoints (Secondary) ..............................................................11 
 
Analysis Populations ........................................................................................................12 
5.
5.1. 
Intent-to-Treat Population .....................................................................................12 
5.2. 
Safety Population..................................................................................................12 
5.3. 
Pharmacokinetic Concentration Population...........................................................12 
5.4. 
Pharmacokinetic Parameters Population ..............................................................12 
5.5. 
Protocol Deviations...............................................................................................12 
 
General Aspects for Statistical Analysis ...........................................................................13 
6.
6.1. 
General Methods ..................................................................................................13 
6.2. 
Key Definitions......................................................................................................14 
6.3. 
Missing Data.........................................................................................................14 
6.4. 
Visit Windows .......................................................................................................14 
 
Demographic and Baseline Characteristics ......................................................................15 
7.
7.1. 
Subject Disposition and Withdrawals ....................................................................15 
7.2. 
Demographic and Baseline Characteristics...........................................................15 


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7.3.
Medical History .....................................................................................................15
 
Analysis Of Pharmacokinetics ..........................................................................................16 
8.
8.1. 
PK Sampling Schedule .........................................................................................16 
8.2. 
Derived PK Parameters ........................................................................................16 
8.3. 
Summary of PK Variables.....................................................................................18 
8.4. 
Assessment of Dose Proportionality .....................................................................19 
 
Anti Drug Antibodies.........................................................................................................20 
9.
 
Safety...............................................................................................................................21 
10.
10.1. 
Exposure ..............................................................................................................21 
10.2. 
Adverse Events.....................................................................................................21 
10.3. 
Laboratory Evaluations .........................................................................................21 
10.4. 
Vital Signs.............................................................................................................22 
10.5. 
12-Lead ECG........................................................................................................22 
10.6. 
Medication ............................................................................................................22 
10.7. 
Other Safety .........................................................................................................22 
 
Interim Analyses...............................................................................................................23 
11.
 
Changes from Analysis Planned in Protocol.....................................................................24 
12.
 
Reference List ..................................................................................................................25 
13.
 
Programming Considerations ...........................................................................................26 
14.
14.1. 
General Considerations ........................................................................................26 
14.2. 
Table, Listing, and Figure Format .........................................................................26 
14.2.1.
General ................................................................................................................26
14.2.2.
Headers................................................................................................................26
14.2.3.
Display Titles........................................................................................................27
14.2.4.
Column Headers ..................................................................................................27
14.2.5.
Body of the Data Display .....................................................................................27
14.2.6.
Footnotes .............................................................................................................29
 
Quality Control .................................................................................................................31 
15.
 
Tables, Listings and Figures Shells ..................................................................................32 
16.


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Glossary of Abbreviations
1.
Abbreviation
Description
AE
Adverse event
ATC
Anatomical Therapeutic Chemical
AUC
Area under the curve
BMI
Body mass index
BLQ
Below the quantification limit
CI
Confidence interval
CRF
Case Report Form
CV
Coefficient of variation
ECG
Electrocardiogram
eCRF
Electronic case report form
ITT
Intent-to-Treat
MAD 
Multiple ascending dose
MedDRA
Medical Dictionary for Regulatory Activities
OLS
Ordinary least squares
PD 
Pharmacodynamic
PK
Pharmacokinetic
PT
Preferred term
RTF
Rich text format
SAD 
Single ascending dose
SAE
Serious adverse event
SAP
Statistical analysis plan
SAS
Statistical Analysis System
SD
Standard deviation
SOC
System organ class
SOP
Standard Operating Procedure
SRC
Safety Review Committee
TEAE
Treatment Emergent Adverse Event
TLF
Tables, Listings and Figures 
WHO
World Health Organization


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Purpose
2.
The purpose of this statistical analysis plan (SAP) is to ensure that the data listings, summary tables and 
figures which will be produced, and the statistical methodologies that will be used, are complete and 
appropriate to allow valid conclusions regarding the study objectives.
This SAP is based on the following documents:
Protocol V3, dated 30-Jan-2020.
Addendum to Clinical Protocol (version 29MAY2019_v2), dated 31-Mar-2020
Electronic Case Report Form (eCRF) version 4.00, dated 19-Mar-2020.
Responsibilities
2.1.
Syneos Health will perform the statistical analyses and are responsible for the production and quality 
control of all tables, listings, figures (TLFs) and Pharmacokinetic (PK) analysis.
Timings of Analyses
2.2.
Interim PK analysis may be performed by the pharmacokineticist after the completion of individual
cohorts.  
The primary analysis of safety and PK is planned after all subjects complete the final study visit or 
terminate early from the study. 


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Study Objectives
3.
Primary Objective
3.1.
The primary objective of this study is: 
To determine the safety and tolerability of 4 single and multiple ascending doses of LSALT
peptide in healthy participants.
Secondary Objective
3.2.
The secondary objective of this study is: 
To evaluate the pharmacokinetics and pharmacodynamics of LSALT peptide in healthy
participants. 
Brief Description
3.3.
This is a double-blind, placebo-controlled, randomized, adaptive design single and multiple ascending 
dose study to evaluate the safety and pharmacokinetics of LSALT peptide in healthy participants.
To establish a safe starting dose of LSALT peptide, unblinded low dose escalation will first be performed 
in a small cohort of participants. 0.01 mg of LSALT peptide will be administered intravenously (IV) once. If 
no adverse effects are observed following 72 hours, subsequent single (n=1) participants will be 
administered escalating doses of 0.1 mg, 0.3 mg and 0.5 mg every 72 hours. If no adverse effects are 
observed at the 0.5 mg dose, then the study will proceed to the first cohort of 8 participants (6 active 
treatment, 2 placebo per dose level) who will receive 1.0 mg of LSALT peptide in a double-blinded 
fashion. Safety, tolerability, PK and PD will be assessed before escalating to the next cohort. Dosing will 
be completed in two sequential cohorts of 8 participants using doses of 2.5 mg and 5.0 mg. The first 2 
participants in each blinded cohort will act as sentinels (1 treatment, 1 placebo) who must show no 
adverse effects before continuing the study under the current design.
Once safety, PK and PD data are completed in the single ascending dose (SAD) cohort, and the LSALT 
peptide is determined to be safe and well-tolerated by the Safety Review Committee (SRC), the multiple 
ascending dose arm of the study will proceed. The multiple ascending dose arm will consist of 3 cohorts 
of 8 participants receiving 3 independent doses of the LSALT peptide or placebo once or twice daily for 3 
consecutive days. The doses for this arm of the study will consist of the 3 highest doses determined by 
the SRC to be safe in the SAD cohort. The first cohort will receive drug in a double-blinded fashion. 
Safety, tolerability, PK, and PD will be assessed before escalating to the next cohort. Each cohort will 
consist of 6 active treatment, 2 placebo per dose level. The first 2 participants in each cohort will act as 
sentinels (1 treatment, 1 placebo) who must show no adverse effects before continuing the study under 
the current design.
Subject Selection
3.4.
Approximately 52 healthy male and female subjects, aged 18-55 years, are planned to be enrolled into
the study. 
Determination of Sample Size
3.5.
No prospective calculations of statistical power have been made. The sample sizes of 4 subjects (low 
dose cohort), 24 subjects for the SAD portion and 24 subjects for the MAD portion of this study have been 
selected to provide information on safety, tolerability, PK and PD following single and multiple doses of 
LSALT peptide. 


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Treatment Assignment
3.6.
All subjects enrolled in this study will receive either LSALT peptide or placebo. The planned dose levels 
are as follows. 
: 
Cohort
Dose
Number of Subjects 
Receiving LSALT
Number of Subjects 
Receiving Placebo
Low Dose
0.01 mg
1
0
Low Dose
0.1 mg
1
0
Low Dose
0.3 mg
1
0
Low Dose
0.5 mg
1
0
: 
Cohort Number
Dose
Number of Subjects 
Receiving LSALT
Number of Subjects 
Receiving Placebo
1 (sentinel group)
1.0 mg
1
1
1
1.0 mg
5
1
2 (sentinel group)
2.5 mg
1
1
2
2.5 mg
5
1
3 (sentinel group)
5.0 mg
1
1
3
5.0 mg
5
1
: 
Cohort Number
Dose
Number of Subjects 
Receiving LSALT
Number of Subjects 
Receiving Placebo
4 (sentinel group)
1.0 mg
1
1
4
1.0 mg
5
1
5 (sentinel group)
2.5 mg
1
1
5
2.5 mg
5
1
6 (sentinel group)
5.0 mg
1
1
6
5.0 mg
5
1
TBD = to be determined.
Randomization and Blinding
3.7.
Computer generated randomization schedules will be prepared prior to the start of the study. The 
schedules will be generated through the statistical analysis system (SAS) software, version 9.4. Block 
randomization will be used.


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Low Dose Subjects will reveive only LSALT peptide. SAD and MAD subjects will be randomly assigned to 
receive either LSALT peptide or matching placebo in a ratio of 3:1 (active: placebo). A Randomization 
Plan will be created (which includes provisions for replacement subjects), and the randomization of 
eligible study participants will be managed as per the plan.
In the event of participant drop-out, participants from the reserve pool will be enrolled in the study and 
randomized. For subjects who are replaced the replacements should take the same treatment 
assignment as the original subject to ensure that the planned treatment allocation ratio is retained.
Participants and the study investigators/personnel will be blinded except for initial low doses of LSALT in 
single subjects which will be open-label. This is a third-party blinded study whereupon the pharmacist (or 
designate) preparing the LSALT peptide or placebo for infusion will be unblinded.


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Endpoints
4.
Safety Endpoints (Primary)
4.1.
The primary safety endpoints are: 
Incidence of AEs. 
Clinical laboratory test results (hematology, chemistry, coagulaton and urinalysis).
Vital sign measurements
12 lead electrocardiogram (ECG) readings
Pharmacokinetic Endpoints (Secondary)
4.2.
The secondary PK endpoints are:
Plasma LSALT concentrations.
Plasma LSALT PK parameters.


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Analysis Populations
5.
All subjects’ inclusion status into each analysis population will be determined after database lock and 
prior to unblinding for the final analysis.
Intent-to-Treat Population
5.1.
The Intent-to-Treat (ITT) Population will comprise all randomized subjects and will be based on the 
randomized treatment, regardless of which treatment the subject actually received. The ITT Population 
will be used for all summaries of baseline and demographic data. In addition, all listings will be produced 
for the ITT Population.
Safety Population
5.2.
The Safety Population will comprise all randomized subjects who receive any amount of study drug and 
will be based on the actual treatment received, if this differs from that to which the subject was 
randomized. The Safety Population will be used for the summaries of all safety and tolerability.
Pharmacokinetic Concentration Population  
5.3.
The PK Concentration Population will comprise all subjects who receive any amount of LSALT, who have 
at least one quantifiable PK concentration and will be based on the actual treatment received, if this 
differs from that to which the subject was randomized. Subjects who receive only placebo will be 
excluded from the PK Concentration Population. The PK Concentration Population will be used for the 
summaries of all PK concentration data.
Pharmacokinetic Parameters Population
5.4.
The PK Population will comprise all randomized subjects who receive any amount of LSALT, have 
sufficient concentration data to support accurate estimation of at least 1 PK parameter (determined at the 
discretion of the pharmacokineticist in consultation with the Sponsor) and will be based on the actual 
treatment received, if this differs from that to which the subject was randomized. Subjects who receive 
only placebo will be excluded from the PK Parameters Population. The PK Parameters Population will be 
used for the summaries/analyses of all PK parameter data.
Protocol Deviations
5.5.
Subject data will be examined for evidence of protocol deviations in order to assess how well the protocol 
was followed. Possible protocol deviations will be independently reviewed and acknowledged by Arch 
Biopartners Inc. 
All protocol deviations will be detailed in the listings. 


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General Aspects for Statistical Analysis
6.
General Methods
6.1.
SAS® for Windows, Release 9.4 (SAS® Institute Inc., Cary, NC, USA) software will be used to perform all 
data analyses. 
All data in the database will be presented in the data listings. Unless otherwise stated, all listings will be 
sorted by cohort, randomized treatment group, subject number and assessment date/time. For the 
purposes of the summary tables, all subjects randomized to placebo will be combined into a single 
placebo group.
All listings and summaries/analyses will be presented separately for each study part. Unless otherwise 
stated, the descriptions of the analyses which follow, apply to both SAD/MAD study parts (Low Dose 
subjects’ results will be listed only). 
The following labels for treatment will be used on all tabulations where the results are displayed by 
treatment, in the following order:
: 
All Placebo
LSALT 1.0 mg
LSALT 2.5 mg
LSALT 5.0 mg
: 
All Placebo
LSALT 1.0 mg
LSALT 2.5 mg
LSALT 5.0 mg
: 
Unless otherwise stated, continuous variables will be summarized using the number of observations (n),
and the statistics mean, median, standard deviation (SD), minimum and maximum. The minimum and 
maximum values will be presented to the same number of decimal places as recorded in the case report 
form (CRF), mean and median will be presented to one more decimal place than the raw data and the SD
will be presented to two more decimal places than the raw data. Summaries of change-from-baseline 
variables will include only subjects who have both a baseline value and corresponding value at the 
timepoint of interest. Categorical variables will be summarized with frequency counts and percentages. 
Percentages will be rounded to one decimal place, with the denominator being the number of subjects in 
the relevant population, unless otherwise stated.


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For the plasma PK data, the data will be rounded to two decimal places in the listings. Summary statistics 
will also include the geometric mean (three decimal places) and geometric coefficient of variation (CV)
(%) (four decimal places). The geometric mean and CV(%) will not be calculated for Tmax, t1/2, %AUCexp
and
z. 
Only data from nominal protocol scheduled visits will be included in the summary tables. Data from 
unscheduled visits will not be included in the summary tables (unless they were used as baseline) but will 
be included in the listings and figures.
Key Definitions
6.2.
: 
In general, baseline will be defined for each subject and will be defined as the last available, non-missing 
assessment results obtained prior to first study drug administration. Unknown, Not Done, Not Applicable 
and other classifications of missing data will not be considered when calculating baseline observations. 
However, valid categorical observations will be considered for baseline calculations.
: 
Study day will be calculated using first study drug administration date as the reference date. If the date of 
interest occurs on or after the first study drug administration date, study day will be calculated as (date of 
interest – first study drug administration date) + 1. If the date of interest occurs prior to the first study drug 
administration date, study day will be calculated as (date of interest – first study drug administration date). 
There will be no study day 0.
Missing Data
6.3.
All withdrawals will be included in all summaries up to the time of withdrawal.
There will be no imputation for missing data, unless otherwise specified.
Visit Windows
6.4.
All assessments will be included in the listings. No visit windows will be applied to assessments.


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Demographic and Baseline Characteristics
7.
Subject Disposition and Withdrawals
7.1.
Subject enrollment and disposition, including reasons for early withdrawal from the study, will be 
summarized by randomized treatment.
All subject disposition parameters will be presented for individual subjects in the listings.
Demographic and Baseline Characteristics
7.2.
Demographic and baseline characteristics (including gender, child bearing potential, age, race, ethnicity,
height, weight and body mass index [BMI]) will be summarized by randomized treatment and overall. 
All demographic and baseline characteristics (and other screening data) will be listed.
Medical History
7.3.
Medical history, urine drug screen and alcohol breath test will be listed only. 


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Analysis Of Pharmacokinetics
8.
All plasma concentration summaries will be conducted on the PK Concentration Population. All plasma 
PK parameter summaries/analyses will be conducted on the PK Parameters Population.
PK Sampling Schedule 
8.1.
: 
PK blood samples: 5 ml of blood will be drawn at 30 minutes pre (+/- 5 minutes) and 15 minutes (+/- 5
minutes), 30 minutes (+/- 5 minutes), 45 minutes (+/- 5 minutes), 1h (+/- 5 minutes), 2h (+/- 5 minutes), 4h 
(+/- 10 minutes), 6h (+/- 10 minutes), 8h (+/- 10 minutes), and 12h (+/- 30 minutes) after the LSALT 
infusion has completed; followed by 24h and 72h samples.
:
Day 1 PK blood samples: 5 ml of blood will be drawn at 30 minutes pre start of infusion (+/- 5 minutes)
and 15 minutes (+/- 5 minutes), 30 minutes (+/- 5minutes), 45 minutes (+/- 5 minutes), 1h (+/- 5 minutes), 
2h (+/- 5 minutes), 4h (+/- 10 minutes), 6h (+/- 10 minutes), 8h (+/- 10 minutes), and 12h (+/- 30minutes)
after the LSALT infusion has completed; followed by 24h sample.
Day 3 PK blood samples: 5 ml of blood will be drawn at 15 minutes (+/- 5 minutes), 30 minutes (+/- 5
minutes), 45 minutes (+/- 5 minutes), 1h (+/- 5 minutes), 2h (+/- 5 minutes), 4h (+/- 10 minutes), 6h (+/- 10
minutes), 8h (+/- 10 minutes), and 12h (+/- 30 minutes) after the 3rd LSALT infusion has completed; 
followed by 72h and 92h samples. 
Derived PK Parameters
8.2.
: 
The following plasma PK parameters will be derived for the SAD study portion. 
Parameter 
Definition 
Method of Determination 
AUC0-24
Area under the plasma concentration-time 
curve, from time 0 to 24 hours. 
Linear trapezoidal method
AUC0-12
Area under the plasma concentration-time 
curve, from time 0 to 12 hours.
Linear trapezoidal method
AUC0-t
Area under the plasma concentration-time 
curve, from time 0 to the last measurable 
concentration. 
Linear trapezoidal method
AUC0-inf
Area under the plasma concentration-time 
curve, from time 0 extrapolated to infinity. 
AUC0-t + Clast/ z, where Clast is 
the last measurable 
concentration.
%AUCexp
Percentage of AUC0-inf due to extrapolation 
from the time of last concentration to 
infinity.
(1 - AUC0-t/AUC0-inf)*100


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Parameter 
Definition 
Method of Determination 
Cmax
Maximum observed plasma concentration.
Observed directly from data
Tmax 
Time to reach Cmax. If the maximum value 
occurs at more than 1 timepoint, Tmax is 
defined as the first timepoint with this 
value. 
Observed directly from data
t1/2
Apparent first-order terminal elimination 
half-life. 
ln(2)/ z
z 
Apparent first-order terminal elimination 
rate constant. 
Estimated by linear regression 
of the terminal elimination 
phase of the log-linear drug 
concentration-time curve
Cl/F
Apparent total body clearance.
Estimated as Dose/AUC0-inf
Vz/F
Apparent volume of distribution.
Estimated as 
Dose/( z × AUC0-inf) 
: 
The following plasma PK parameters will be derived for the MAD study portion, for Day 1 and Day 3. 
Parameter 
Definition 
Method of Determination 
AUC0-24
Area under the plasma concentration-time 
curve, from time 0 to 24 hours. (Day 1)
Linear trapezoidal method
AUC0-12
Area under the plasma concentration-time 
curve, from time 0 to 12 hours. (Day 1)
Linear trapezoidal method
AUC0-tau
Area under the curve over a dosing 
interval at steady state (Day 3 only)
Linear trapezoidal method
AUC0-t
Area under the plasma concentration-time 
curve, from time 0 to the last measurable  
concentration. 
Linear trapezoidal method
AUC0-inf
Area under the plasma concentration-time 
curve, from time 0 extrapolated to infinity. 
AUC0-t + Clast/ z, where Clast is 
the last measurable 
concentration.
%AUCexp
Percentage of AUC0-inf due to extrapolation 
from the time of last concentration to 
(1 - AUC0-t/AUC0-inf)*100


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Parameter 
Definition 
Method of Determination 
infinity.
Cmax
Maximum observed plasma concentration
on. 
Observed directly from data
Tmax
Time to reach Cmax. If the maximum value 
occurs at more than 1 timepoint, Tmax is 
defined as the first timepoint with this 
value. 
Observed directly from data
t1/2
Apparent first-order terminal elimination 
half-life. 
ln(2)/ z
z 
Apparent first-order terminal elimination 
rate constant. 
Estimated by linear regression 
of the terminal elimination 
phase of the log-linear drug 
concentration-time curve. 
Cl/F
Apparent total body clearance.
Estimated as Dose/AUC0-inf
Vz/F
Apparent volume of distribution.
Estimated as 
Dose/
z × AUC0-inf) 
RAUC
Accumulation Ratio for AUC.
AUC0-12 or AUC0-24 Day 3/
AUC0-12 or AUC0-24 Day 1
RCmax
Accumulation Ratio for Cmax.
Cmax Day 3/Cmax Day 1
:
z will be the negative of the estimated slope of the linear regression of the log-transformed 
concentration (natural logarithm) versus time profile in the terminal elimination phase. At least three 
concentration points will be used in estimating 
z. The time point where log-linear 
z calculation begins 
( z Lower), and the actual sampling time of the last quantifiable concentration used to estimate the 
z  ( z
Upper) will be reported with the correlation coefficient from the linear regression to calculate z. 
: tau is the dosing interval for steady-state data. 
Summary of PK Variables
8.3.
Plasma concentrations will be listed and summarized, by nominal sampling time, and cohort/actual 
treatment. Concentrations below the quantification limit (BLQ) will be set to zero in summary tables. BLQ
will be displayed in listings.
Individual subject and mean ± SD profiles of the plasma concentration-time data will be plotted by dose 
level/cohort using actual and nominal times, respectively. These profiles will be presented on both linear-
linear and log-linear scales. 


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For individual plots the BLQ values that occur in a profile before the first measurable concentration will be 
set to zero, and the BLQ values that occur after first measurable concentration will be set to missing. For 
mean plots, BLQ will be set to zero. 
: 
Plasma PK parameters will be listed and summarized descriptively by dose level/cohort. 
For derivation of plasma pharmacokinetic parameters, the BLQ values that occur in a profile before the 
first measurable concentration will be set to zero. The BLQ values that occur after first measurable 
concentration will be set to missing.
Assessment of Dose Proportionality
8.4.
: 
For the SAD and MAD portions, an exploratory assessment of dose proportionality will be undertaken for 
the PK parameters AUC0-t, AUC0-inf, and Cmax (SAD) and AUC0-24 (Day 1), Cmax, AUC0-t, AUC0-inf (Days 1 
and 3) and AUC0-tau (Day 3) (MAD). The power model will be used, and will include the PK parameter as 
the response variable and dose (mg) as the explanatory variable. For this model, the variable dose will be 
treated as a continuous variable. Cohorts that will be considered for the analysis include LSALT dose 
levels
1.0 mg (where a minimum of three different dose levels are required in order to conduct the 
analysis). The form of the model is as follows:
PK Parameter = 
× Dose ×
represents the associated error.
Thus, perfect dose proportionality is met when
(ignoring error). This becomes a linear relationship 
following a natural-log transformation, to which a linear regression will be fit by ordinary least squares 
(OLS): 
ln(PK Parameter) = 
× ln(Dose) + , 
where Dose > 0, and
represents the associated error. 
ill be provided (for each PK parameter 
model), and this will be used to quantify dose proportionality. According to Hummel et al. (2009), the 
following criterion may be used for exploratory dose proportionality evaluations: If the (two-sided) 90% CI 
is wholly contained within the interval, [1+ln(0.5)/ln( ), 1+ln(2)/ln( )], then dose proportionality is 
suggested across the investigated dose range. Here, 
is defined as the ratio of the highest to lowest 
dose. This interval criterion will be reported 
(presented to three decimal places).
The SAS code for the analysis model will follow the format given below (using the Mixed procedure to fit 
the linear regression). The input variables (or datasets) are depicted in slanted red text and have been 
given generic names.
proc mixed data=
order=data;
model
=
/ solution;
estimate 'Beta Estimate' 
1 / cl alpha=0.1;
ods output estimates = 
; 
run;
The PK parameter values estimated from the power model will be plotted against dose. This plot will also 
include individual subject values ± SD (separately by dose level).


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Anti Drug Antibodies
9.
Analysis of anti drug antibody data is outside the scope of this SAP. The sample collection dates and 
times will be listed.


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Safety
10.
Summaries of safety and tolerability data will be based on the Safety Population.
Exposure
10.1.
Study drug administration will be listed. For the MAD portion only, the exposure to each dose will be 
summarized by actual treatment and overall.  
Adverse Events
10.2.
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 
21.0 or higher. AEs will be grouped by system organ class (SOC) and preferred term (PT) and 
summarized by actual treatment. The summary tables will present the number and percentage of total 
subjects and number of events by SOC and by PT.
All AE summaries will be restricted to treatment emergent AEs (TEAEs) only. Treatment emergent AEs 
are defined as AEs that commence on or after the time of first study drug administration. Adverse events 
without an onset date or time or AEs with an onset date of the date of first study drug administration but 
without an onset time will be defined as treatment emergent, except if an incomplete date (e.g., month 
and year) clearly indicates that the event started prior to administration of first study drug or if the AE stop 
date indicates that the event started and stopped prior to administration of first study drug. 
Treatment-emergent AEs will be summarized by actual treatment. The number and percentage of 
subjects experiencing AEs and the number of TEAEs will be tabulated. Subjects who experience the 
same AE (in terms of MedDRA preferred term) more than once will only be counted once for that event, 
however, the total number of events will also be counted per category. This also applies to sub-categories 
displayed in the summaries.
The following summaries will be presented:
Overall summary of TEAEs
TEAEs by SOC and PT
TEAEs by SOC, PT, and severity
TEAEs by SOC, PT, and relationship to study drug
 
Serious TEAEs by SOC and PT
All AEs will be listed. This will include a separate listing of serious adverse events (SAEs), and Non-
TEAEs. 
Laboratory Evaluations
10.3.
Laboratory data (hematology, chemistry and coagulation) will be summarized at each protocol-scheduled 
visit, by actual treatment. Actual values and actual changes from baseline will be presented.
In addition, a shift table representing the categorical change in laboratory results interpretation (normal, 
abnormal not clinically significant, or abnormal clinically significant) from baseline to each post baseline 
visit will be presented.


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Urinalysis results evaluation will be summarized at each protocol-scheduled timepoint, by actual 
treatment, using frequency tabulations.
High and low/abnormal results will be flagged in the listings.
Vital Signs 
10.4.
Vital sign measurements will be summarized at each protocol-scheduled timepoint, by actual treatment. 
Actual values and actual changes from baseline will be presented.
In addition, a shift table representing the categorical change in vital signs interpretation (normal, abnormal 
not clinically significant, or abnormal clinically significant) from baseline to each post baseline visit will be 
presented.
Abnormal results will be flagged in the listings.
12-Lead ECG
10.5.
ECG values will be summarised at each protocol-scheduled visit, by actual treatment. Actual values and 
actual changes from baseline will be presented. 
In addition, a shift table representing the categorical change in overall ECG interpretation (normal, 
abnormal not clinically significant, or abnormal clinically significant) from baseline to each post baseline 
visit will be presented.
Abnormal results will be flagged in the listings.
Medication
10.6.
Concomitant medications will be coded using the latest version of the World Health Organisation (WHO) 
Drug coding dictionary. The version will be presented in the table/listing footnotes.
Prior and concomitant medications will be grouped by Anatomical Therapeutic Chemical (ATC) level 2 
class and PT. The summary tables will show the number and percentage of subjects by ATC class, PT 
and by actual treatment. Prior medications are those medications that were stopped prior to first study 
drug administration. Concomitant medications are medications taken at least once after first study drug 
administration. Medications stopped on the same day as study treatment will be considered as 
concomitant medications. Concomitant medications will be summarized by actual treatment and class. 
Prior medications will be listed only. For the summaries of concomitant medications, subjects who take 
the same medication (in terms of PT and ATC) more than once will only be counted once for that 
medication.
Other Safety
10.7.
Physical examination, chest X-ray, serology, follicle stimulating hormone and pregnancy data will be listed 
only.


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Interim Analyses
11.
An interim analysis may be performed by the pharmacokineticist after each cohort. The bioanalytical 
concentration data will be provided to the pharmacokineticist for the calculation of the PK parameters 
described in section 8.2 using the scheduled sampling times. Descriptive statistics will be calculated on 
the PK variables as described in section 8.3. These results will be provided as Phoenix WinNonlin outputs 
in Word format. Blinded listings of data may be provided. No inferential statistical analysis will be 
performed before the finalization of this SAP.


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 Changes from Analysis Planned in Protocol
12.
None.


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Reference List
13.
Hummel J., McKendrick S., Brindley C. and French, R. Exploratory assessment of dose proportionality: 
review of current approaches and proposal for a practical criterion. Pharmaceut. Statist. 2009; 8: 38-49.


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Programming Considerations
14.
All TLFs, and statistical analyses will be generated using SAS® for Windows, Release 9.4 (SAS® Institute 
Inc., Cary, NC, USA). Computer-generated table, listing and figure output will adhere to the following 
specifications. 
For all PK analyses, Phoenix® WinNonlin® version 8.0 (Certara USA, Inc., Princeton, NJ) will be used.
General Considerations
14.1.
One SAS program can create several outputs.
 
Each output will be stored in a separate file.
Output files will be delivered in rich text format (RTF) that can be manipulated in MS Word. 
Numbering of TLFs will follow ICH E3 guidance.
Table, Listing, and Figure Format
14.2.
General
14.2.1.
All TLFs will be produced in landscape format, unless otherwise specified.
All TLFs will be produced using the Courier New font, size 9 
The data displays for all TLFs will have a minimum 1-inch margin on all 4 sides.
Headers and footers for figures will be in Courier New font, size 9. 
Legends will be used for all figures with more than 1 variable, group, or item displayed.
TLFs will be in black and white (no color), unless otherwise specified
Specialized text styles, such as bolding, italics, borders, shading, and superscripted and 
subscripted text, will not be used in the TLFs, unless otherwise specified. On some occasions, 
superscripts 1, 2, or 3 may be used (see below).
Only standard keyboard characters will be used in the TLFs. Special characters, such as non-
printable control characters, printer-specific, or font-specific characters, will not be used. 
Hexadecimal-derived characters will be used, where possible, if they are appropriate to help 
employed on a case-by-case basis.
Mixed case will be used for all titles, footnotes, column headers, and programmer-supplied formats, 
as appropriate.
Headers
14.2.2.
All output should have the following header at the top left of each page:
Arch Biopartners Inc. (Syneos Health study number 7001012) 


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All output should have Page n of N at the top or bottom right corner of each page. TLFs are
internally paginated in relation to the total length (i.e., the page number should appear sequentially 
as page n of N, where N is the total number of pages in the table).
The date output was generated should appear along with the program name as a footer on each 
page.
Display Titles
14.2.3.
Each TLF are identified by the designation and a numeral. (i.e., Table 14.1.1). ICH E3 numbering is 
strongly recommended, but sponsor preferences are obtained before final determination A decimal 
system (x.y and x.y.z) are used to identify TLFs with related contents. The title is centered. The 
analysis set are identified on the line immediately following the title. The title and table designation 
are single spaced. A solid line spanning the margins will separate the display titles from the column 
headers. There will be 1 blank line between the last title and the solid line.
Table x.y.z
First Line of Title
Second Line of Title if Needed
Column Headers
14.2.4.
Column headings are displayed immediately below the solid line described above in initial upper-
case characters. 
In the case of efficacy tables, the variable (or characteristic) column will be on the far left followed 
by the treatment group columns and total column (if applicable). P-values may be presented under 
the total column or in separate p-value column (if applicable). Within-treatment comparisons may 
have p-values presented in a row beneath the summary statistics for that treatment.
For numeric variables, include “unit” in column or row heading when appropriate.
Analysis set sizes will be presented for each treatment group in the column heading as (N=xx) (or 
in the row headings, if applicable). This is distinct from the ‘n’ used for the descriptive statistics 
representing the number of subjects in the analysis set.
The order of treatments in the tables and listings will be Placebo first in the case of placebo 
controlled studies and Active comparators first in the case of active comparator trials, followed by a 
total column (if applicable).
Body of the Data Display
14.2.5.
14.2.5.1.
Data in columns of a table or listing are formatted as follows:
 Alphanumeric values are left-justified;
 Whole numbers (e.g., counts) are right-justified; and
 Numbers containing fractional portions are decimal aligned.


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14.2.5.2.
Units will be included where available
If the categories of a parameter are ordered, then all categories between the maximum and 
minimum category are presented in the table, even if n=0 for all treatment groups in a given 
category that is between the minimum and maximum level for that parameter. For example, the 
frequency distribution for symptom severity would appear as:
Severity 
Rating
N
severe
0
moderate
8
mild
3
Where percentages are presented in these tables, zero percentages will not be presented and so counts 
of 0 will be presented as 0 and not as 0 (0%).
If the categories are not ordered (e.g., Medical History, Reasons for Discontinuation from the 
Study, etc.), then only those categories for which there is at least 1 subject represented in 1 or 
more groups are included.
An Unknown or Missing category are added to each parameter for which information is not 
available for 1 or more subjects. 
Unless otherwise specified, the estimated mean and median for a set of values are printed out to
one more decimal places than the original values, and standard deviations are printed out to two 
more decimal places than the original values. The minimum and maximum should report the same 
significant digits as the original values. For example, for systolic blood pressure:
N
XX
Mean
XXX.X
Std Dev
X.XX
Median
XXX.X
Minimum
XXX
Maximum
XXX
 P-values are output in the format: “0.xxx”, where xxx is the value rounded to 3 decimal places. 
Every p-value less than 0.001 will be presented as <0.001. If the p-value is returned as >0.999, 
then present as >0.999
Percentage values are printed to one decimal place, in parentheses with no spaces, one space 
after the count (e.g., 7 (12.8%), 13 (5.4%)). Pre-determine how to display values that round down 
to 0.0.  A common convention is to display as '<0.1', or as appropriate with additional decimal 
places. Unless otherwise noted, for all percentages, the number of subjects in the analysis set for 
the treatment group who have an observation will be the denominator. Percentages after zero 
counts should not be displayed and percentages equating to 100% are presented as 100%, without 
decimal places. 


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Tabular display of data for medical history, prior/concomitant medications, and all tabular displays 
of adverse event data are presented by the body system, treatment class, or SOC with the highest 
occurrence in the active treatment group in decreasing order, assuming all terms are coded. Within 
the body system, drug class and SOC, medical history (by preferred term), drugs (by ATC1 code), 
and adverse events (by preferred term) are displayed in decreasing order. If incidence for more 
than 1 term is identical, they should then be sorted alphabetically. Missing descriptive statistics or 
p-values which cannot be estimated are reported as “-”.
The percentage of subjects is normally calculated as a proportion of the number of subjects 
assessed in the relevant treatment group (or overall) for the analysis set presented. However, 
careful consideration is required in many instances due to the complicated nature of selecting the 
denominator, usually the appropriate number of subjects exposed. Describe details of this in 
footnotes or programming notes.
For categorical summaries (number and percentage of subjects) where a subject can be included 
in more than one category, describe in a footnote or programming note if the subject are included 
in the summary statistics for all relevant categories or just 1 category and the criteria for selecting 
the criteria.
Where a category with a subheading (such as system organ class) has to be split over more than 
one page, output the subheading followed by “(cont)” at the top of each subsequent page.  The 
overall summary statistics for the subheading should only be output on the first relevant page.
14.2.5.3.
Listings will be sorted for presentation in order of treatment groups as above, subject number, 
visit/collection day, and visit/collection time.
Missing data are represented on subject listings as either a hyphen (“-”) with a corresponding 
footnote (“- = unknown or not evaluated”), or as “N/A”, with the footnote “N/A = not applicable”, 
whichever is appropriate.
Dates are printed in SAS DATE9.format (“ddMMMyyyy”: 01JUL2000). Missing portions of dates are
represented on subject listings as dashes (--JUL2000). Dates that are missing because they are 
not applicable for the subject are output as “N/A”, unless otherwise specified.
All observed time values are to be presented using a 24-hour clock HH:MM or HH:MM:SS format 
(e.g., 11:26:45, or 11:26). Time will only be reported if it was measured as part of the study.
Units will be included where available
14.2.5.4.
Unless otherwise specified, for all figures, study visits will be displayed on the X-axis and endpoint 
(e.g., treatment mean change from Baseline) values will be displayed on the Y-axis.
Footnotes
14.2.6.
A solid line spanning the margins will separate the body of the data display from the footnotes. 


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All footnotes will be left justified with single-line spacing immediately below the solid line
underneath the data display.
Footnotes should always begin with “Note:” if an informational footnote, or 1, 2, 3, etc. if a 
reference footnote. Each new footnote should start on a new line, where possible.
Subject specific footnotes are avoided, where possible.
Footnotes will be used sparingly and add value to the table, figure, or data listing. If more than six 
lines of footnotes are planned, then a cover page may be used to display footnotes, and only those 
essential to comprehension of the data will be repeated on each page. 
The last line of the footnote section will be a standard source line that indicates the name of the 
program used to produce the data display and date the program was run (i.e., ‘Program : 
myprogram.sas’).


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Quality Control
15.
SAS programs are developed to produce output such as analysis data sets, summary tables, data 
listings, figures or statistical analyses. These will be developed and undergo quality control as per SOPs 
2800 and 2801.


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Tables, Listings and Figures Shells
16.


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Tables, Listings and Figures Shells
for Statistical Analysis of AB001
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic 
profile of LSALT peptide in healthy participants
Prepared for:
Arch Biopartners Inc.
Prepared by:
Version Number:
v2.0
Author:
Konstantine Dres
Date:
2-Apr-2020


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List of Tables, Listings and Figures
Table 14.1.1.2     Enrolment and Disposition – SAD (Intent-to-Treat Population) ...................................................................... 45
Table 14.1.1.3     Enrolment and Disposition – MAD (Intent-to-Treat Population) ...................................................................... 46
Table 14.1.2.2     Demographic Characteristics – SAD (Intent-to-Treat Population) .................................................................... 47
Table 14.1.2.3     Demographic Characteristics – MAD (Intent-to-Treat Population) .................................................................... 49
Table 14.1.3.2     Concomitant Medications – SAD (Safety Population) ................................................................................. 51
Table 14.1.3.3     Concomitant Medications – MAD (Safety Population) ................................................................................. 52
Table 14.1.4.3     Exposure – MAD (Safety Population) ................................................................................................ 53
Table 14.2.1.1.1.2     Plasma Pharmacokinetic Concentrations – SAD (Pharmacokinetic Concentration Population) ........................................ 54
Table 14.2.1.1.1.3     Plasma Pharmacokinetic Concentrations – MAD (Pharmacokinetic Concentration Population) ........................................ 55
Figure 14.2.1.1.2.2     Individual Plasma Pharmacokinetic Concentrations by Treatment Group – SAD (Pharmacokinetic Concentration Population) ......... 56
Figure 14.2.1.1.2.3     Individual Plasma Pharmacokinetic Concentrations by Treatment Group – MAD (Pharmacokinetic Concentration Population) ......... 57
Figure 14.2.1.1.3.2     Individual Plasma Pharmacokinetic Concentrations (Log-Scale) by Treatment Group – SAD (Pharmacokinetic Concentration Population)
............................................................................................................................... 58
Figure 14.2.1.1.3.3     Individual Plasma Pharmacokinetic Concentrations (Log-Scale) by Treatment Group – MAD (Pharmacokinetic Concentration Population)
............................................................................................................................... 59
Figure 14.2.1.1.4.2     Mean Plasma Pharmacokinetic Concentrations – SAD (Pharmacokinetic Concentration Population) .................................. 60
Figure 14.2.1.1.4.3     Mean Plasma Pharmacokinetic Concentrations – MAD (Pharmacokinetic Concentration Population) .................................. 61
Figure 14.2.1.1.5.2     Mean Plasma Pharmacokinetic Concentrations (Log-Scale) – SAD (Pharmacokinetic Concentration Population) ...................... 62
Figure 14.2.1.1.5.3     Mean Plasma Pharmacokinetic Concentrations (Log-Scale) – MAD (Pharmacokinetic Concentration Population) ...................... 63
Table 14.2.1.2.1.2     Plasma Pharmacokinetic Parameters – SAD (Pharmacokinetic Parameters Population) ............................................... 64


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Table 14.2.1.2.1.3     Plasma Pharmacokinetic Parameters – MAD (Pharmacokinetic Parameters Population) ............................................... 65
Table 14.2.1.2.2.2     Analysis of Dose Proportionality – SAD (Pharmacokinetic Parameters Population) ................................................ 66
Table 14.2.1.2.2.3     Analysis of Dose Proportionality – SAD (Pharmacokinetic Parameters Population) ................................................ 67
Figure 14.2.1.2.3.2     Estimated Pharmacokinetic Parameters (Power Model) – SAD (Pharmacokinetic Parameters Population) ............................. 68
Figure 14.2.1.2.3.3     Estimated Pharmacokinetic Parameters (Power Model) – SAD (Pharmacokinetic Parameters Population) ............................. 69
Table 14.3.1.1.2     Treatment Emergent Adverse Events Overall Summary – SAD (Safety Population) ..................................................... 70
Table 14.3.1.1.3     Treatment Emergent Adverse Events Overall Summary – MAD (Safety Population) ..................................................... 71
Table 14.3.1.2.2     Treatment Emergent Adverse Events – SAD (Safety Population) ..................................................................... 72
Table 14.3.1.2.3     Treatment Emergent Adverse Events – MAD (Safety Population) ..................................................................... 73
Table 14.3.1.3.2     Treatment Emergent Adverse Events by Severity – SAD (Safety Population) ......................................................... 74
Table 14.3.1.3.3     Treatment Emergent Adverse Events by Severity – MAD (Safety Population) ......................................................... 75
Table 14.3.1.4.2     Treatment Emergent Adverse Events by Relationship to Study Drug – SAD (Safety Population) ....................................... 76
Table 14.3.1.4.3     Treatment Emergent Adverse Events by Relationship to Study Drug – MAD (Safety Population) ....................................... 77
Table 14.3.1.5.2     Serious Treatment Emergent Adverse Events – SAD (Safety Population) ............................................................. 78
Table 14.3.1.5.3     Serious Treatment Emergent Adverse Events – MAD (Safety Population) ............................................................. 79
Table 14.3.4.1.1.2     Hematology – SAD (Safety Population) .......................................................................................... 80
Table 14.3.4.1.1.3     Hematology – MAD (Safety Population) .......................................................................................... 82
Table 14.3.4.1.2.2     Hematology Shifts From Baseline – SAD (Safety Population) ..................................................................... 84
Table 14.3.4.1.2.3     Hematology Shifts From Baseline – MAD (Safety Population) ..................................................................... 85
Table 14.3.4.1.3.2     Chemistry – SAD (Safety Population) ........................................................................................... 86


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Table 14.3.4.1.3.3     Chemistry – MAD (Safety Population) ........................................................................................... 88
Table 14.3.4.1.4.2     Chemistry Shifts From Baseline – SAD (Safety Population) ...................................................................... 90
Table 14.3.4.1.4.3     Chemistry Shifts From Baseline – MAD (Safety Population) ...................................................................... 91
Table 14.3.4.1.3.2     Coagulation – SAD (Safety Population) ......................................................................................... 92
Table 14.3.4.1.5.3     Coagulation – MAD (Safety Population) ......................................................................................... 94
Table 14.3.4.1.6.2     Coagulation Shifts From Baseline – SAD (Safety Population) .................................................................... 96
Table 14.3.4.1.6.3     Coagulation Shifts From Baseline – MAD (Safety Population) .................................................................... 97
Table 14.3.4.1.7.2     Urinalysis Results Evaluation – SAD (Safety Population) ....................................................................... 98
Table 14.3.4.1.7.3
Urinalysis Results Evaluation – MAD (Safety Population) ....................................................................... 99
Table 14.3.4.2.1.2     Vital Signs – SAD (Safety Population) ........................................................................................ 100
Table 14.3.4.2.1.3     Vital Signs – MAD (Safety Population) ........................................................................................ 102
Table 14.3.4.2.2.2     Vital Signs Shifts from Baseline – SAD (Safety Population) ................................................................... 104
Table 14.3.4.2.2.3     Vital Signs Shifts from Baseline – MAD (Safety Population) ................................................................... 105
Table 14.3.4.3.1.2     12-Lead Electrocardiogram – SAD (Safety Population) .......................................................................... 106
Table 14.3.4.3.1.3     12-Lead Electrocardiogram – MAD (Safety Population) .......................................................................... 108
Table 14.3.4.3.2.2     12-Lead Electrocardiogram Shifts from Baseline – SAD (Safety Population) ..................................................... 110
Table 14.3.4.3.2.3     12-Lead Electrocardiogram Shifts from Baseline – MAD (Safety Population) ..................................................... 111
Table 14.3.4.4.1.3     Anti-Drug Antibodies – MAD (Safety Population) ............................................................................... 112
Listing 16.2.1.1.1     Subject Enrollment – Low Dose (Intent-to-Treat Population) ................................................................... 113
Listing 16.2.1.1.2     Subject Enrollment – SAD (Intent-to-Treat Population) ........................................................................ 114


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Listing 16.2.1.1.3     Subject Enrollment – MAD (Intent-to-Treat Population) ........................................................................ 115
Listing 16.2.1.2.1     Subject Disposition – Low Dose (Intent-to-Treat Population) .................................................................. 116
Listing 16.2.1.2.2     Subject Disposition - SAD (Intent-to-Treat Population) ....................................................................... 117
Listing 16.2.1.2.3     Subject Disposition – MAD (Intent-to-Treat Population) ....................................................................... 118
Listing 16.2.2.1
Protocol Deviations – Low Dose (Intent-to-Treat Population) .................................................................... 119
Listing 16.2.2.2     Protocol Deviations – SAD (Intent-to-Treat Population) ......................................................................... 120
Listing 16.2.2.3     Protocol Deviations – MAD (Intent-to-Treat Population) ......................................................................... 121
Lising 16.2.3.1.1     Eligibility Criteria – Low Dose (Intent-to-Treat Population) .................................................................. 122
Lising 16.2.3.1.2     Eligibility Criteria – SAD (Intent-to-Treat Population) ....................................................................... 123
Lising 16.2.3.1.3     Eligibility Criteria – MAD (Intent-to-Treat Population) ....................................................................... 124
Listing 16.2.4.1.1     Demographic Characteristics – Low Dose (Intent-to-Treat Population) .......................................................... 125
Listing 16.2.4.1.2
Demographic Characteristics – SAD (Intent-to-Treat Population) ............................................................... 126
Listing 16.2.4.1.3     Demographic Characteristics – MAD (Intent-to-Treat Population) ............................................................... 127
Listing 16.2.4.2.1     Medical History – Low Dose (Intent-to-Treat Population) ...................................................................... 128
Listing 16.2.4.2.2     Medical History – SAD (Intent-to-Treat Population) ........................................................................... 129
Listing 16.2.4.2.3     Medical History – MAD (Intent-to-Treat Population) ........................................................................... 130
Listing 16.2.4.3.1     Alcohol Breath Test – Low Dose (Intent-to-Treat Population) .................................................................. 131
Listing 16.2.4.3.2     Alcohol Breath Test – SAD (Intent-to-Treat Population) ....................................................................... 132
Listing 16.2.4.3.3
Alcohol Breath Test – MAD (Intent-to-Treat Population) ....................................................................... 133
Listing 16.2.4.4.1     Urine Drug Screen – Low Dose (Intent-to-Treat Population) .................................................................... 134


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Listing 16.2.4.4.2     Urine Drug Screen – SAD (Intent-to-Treat Population) ......................................................................... 135
Listing 16.2.4.4.3     Urine Drug Screen – MAD (Intent-to-Treat Population) ......................................................................... 136
Listing 16.2.4.5.1     Serology – Low Dose (Intent-to-Treat Population) ............................................................................. 137
Listing 16.2.4.5.2     Serology – SAD (Intent-to-Treat Population) .................................................................................. 138
Listing 16.2.4.5.3     Serology – MAD (Intent-to-Treat Population) .................................................................................. 139
Listing 16.2.4.6.1     Serum Follicle Stimulating Hormone – Low Dose (Intent-to-Treat Population) ................................................... 140
Listing 16.2.4.6.2     Serum Follicle Stimulating Hormone – SAD (Intent-to-Treat Population) ........................................................ 141
Listing 16.2.4.6.3     Serum Follicle Stimulating Hormone – MAD (Intent-to-Treat Population) ........................................................ 142
Listing 16.2.4.7.1     Pregnancy – Low Dose (Intent-to-Treat Population) ............................................................................ 143
Listing 16.2.4.7.2     Pregnancy – SAD (Intent-to-Treat Population) ................................................................................. 144
Listing 16.2.4.7.3     Pregnancy – MAD (Intent-to-Treat Population) ................................................................................. 145
Listing 16.2.4.8.1     Prior and Concomitant Medications – Low Dose (Intent-to-Treat Population) .................................................... 146
Listing 16.2.4.8.2     Prior and Concomitant Medications – SAD (Intent-to-Treat Population) ......................................................... 147
Listing 16.2.4.9.3     Prior and Concomitant Medications – MAD (Intent-to-Treat Population) ......................................................... 148
Listing 16.2.5.1.1     Study Drug Administration – Low Dose (Intent-to-Treat Population) ............................................................ 149
Listing 16.2.5.1.2     Study Drug Administration – SAD (Intent-to-Treat Population) ................................................................. 150
Listing 16.2.5.1.3     Study Drug Administration – MAD (Intent-to-Treat Population) ................................................................. 151
Listing 16.2.5.2.1     Randomization – Low Dose (Intent-to-Treat Population) ........................................................................ 152
Listing 16.2.5.2.2     Randomization – SAD (Intent-to-Treat Population) ............................................................................. 153
Listing 16.2.5.2.3     Randomization – MAD (Intent-to-Treat Population) ............................................................................. 154


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Listing 16.2.7.1.1     Adverse Events – Low Dose (Intent-to-Treat Population) ....................................................................... 155
Listing 16.2.7.1.2     Adverse Events – SAD (Intent-to-Treat Population) ............................................................................ 156
Listing 16.2.7.1.3     Adverse Events – MAD (Intent-to-Treat Population) ............................................................................ 157
Listing 16.2.7.2.1     Serious Adverse Events – Low Dose (Intent-to-Treat Population) ............................................................... 158
Listing 16.2.7.2.2     Serious Adverse Events – SAD (Intent-to-Treat Population) .................................................................... 159
Listing 16.2.7.2.3     Serious Adverse Events – MAD (Intent-to-Treat Population) .................................................................... 160
Listing 16.2.7.3.1     Non-Treatment-Emergent Adverse Events – Low Dose (Intent-to-Treat Population) ................................................ 161
Listing 16.2.7.3.2     Non-Treatment-Emergent Adverse Events – SAD (Intent-to-Treat Population) ..................................................... 162
Listing 16.2.7.3.3     Non-Treatment-Emergent Adverse Events – MAD (Intent-to-Treat Population) ..................................................... 163
Listing 16.2.8.1.1.1     Hematology – Low Dose (Intent-to-Treat Population) ......................................................................... 164
Listing 16.2.8.1.1.2     Hematology – SAD (Intent-to-Treat Population) .............................................................................. 165
Listing 16.2.8.1.1.3
Hematology – MAD (Intent-to-Treat Population) .............................................................................. 166
Listing 16.2.8.1.2.1     Chemistry – Low Dose (Intent-to-Treat Population) .......................................................................... 167
Listing 16.2.8.1.2.2     Chemistry – SAD (Intent-to-Treat Population) ............................................................................... 168
Listing 16.2.8.1.2.3     Chemistry – MAD (Intent-to-Treat Population) ............................................................................... 169
Listing 16.2.8.1.3.1     Coagulation – Low Dose (Intent-to-Treat Population) ........................................................................ 170
Listing 16.2.8.1.3.2     Coagulation – SAD (Intent-to-Treat Population) ............................................................................. 171
Listing 16.2.8.1.3.3     Coagulation – MAD (Intent-to-Treat Population) ............................................................................. 172
Listing 16.2.8.1.4.1     Urinalysis – Low Dose (Intent-to-Treat Population) ......................................................................... 173
Listing 16.2.8.1.4.2     Urinalysis – SAD (Intent-to-Treat Population) .............................................................................. 174


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Listing 16.2.8.1.4.3     Urinalysis – MAD (Intent-to-Treat Population) .............................................................................. 175
Listing 16.2.8.2.1.1     Vital Signs – Low Dose (Intent-to-Treat Population) ........................................................................ 176
Listing 16.2.8.2.1.2     Vital Signs – SAD (Intent-to-Treat Population) ............................................................................. 177
Listing 16.2.8.2.1.3     Vital Signs – MAD (Intent-to-Treat Population) ............................................................................. 178
Listing 16.2.8.2.2.1     12-Lead Electrocardiogram – Low Dose (Intent-to-Treat Population) .......................................................... 179
Listing 16.2.8.2.2.2     12-Lead Electrocardiogram – SAD (Intent-to-Treat Population) ............................................................... 180
Listing 16.2.8.2.2.3     12-Lead Electrocardiogram – MAD (Intent-to-Treat Population) ............................................................... 181
Listing 16.2.8.2.3.1     Physical Examination – Low Dose (Intent-to-Treat Population) ............................................................... 182
Listing 16.2.8.2.3.2     Physical Examination – SAD (Intent-to-Treat Population) .................................................................... 183
Listing 16.2.8.2.3.3 
Physical Examination – MAD (Intent-to-Treat Population) .................................................................... 184
Listing 16.2.8.2.4.1     Chest X-Ray – Low Dose (Intent-to-Treat Population) ........................................................................ 185
Listing 16.2.8.2.4.2     Chest X-Ray – SAD (Intent-to-Treat Population) ............................................................................. 186
Listing 16.2.8.2.4.3     Chest X-Ray – MAD (Intent-to-Treat Population) ............................................................................. 187
Listing 16.2.8.2.5.2     Plasma Pharmacokinetic Concentrations – SAD (Intent-to-Treat Population) ................................................... 188
Listing 16.2.8.2.5.3     Plasma Pharmacokinetic Concentrations – MAD (Intent-to-Treat Population) ................................................... 189
Listing 16.2.8.2.6.2     Plasma Pharmacokinetic Parameters – SAD (Intent-to-Treat Population) ....................................................... 190
Listing 16.2.8.2.6.3     Plasma Pharmacokinetic Parameters – MAD (Intent-to-Treat Population) ....................................................... 191
Listing 16.2.8.2.7.3     Anti-Drug Antibody – MAD (Intent-to-Treat Population) ...................................................................... 192


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For the SAD study, The following labels for treatment group will be used on all tabulations, in the following order:
All Placebo
LSALT 1.0 mg
LSALT 2.5 mg
LSALT 5.0 mg
For the MAD study, The following labels for treatment group will be used on all tabulations, in the following order:
All Placebo
LSALT TBD mg
LSALT TBD mg


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All listings will be separated by study part, and sorted by cohort, treatment group, subject number and assessment date/time, in the following order:
Low Dose 
LSALT 0.01 mg
LSALT 0.1 mg
LSALT 0.3 mg
LSALT 0.5 mg
SAD
Cohort 1/Placebo
Cohort 1/LSALT 1.0 mg
Cohort 2/Placebo
Cohort 2/LSALT 2.5 mg
etc.


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MAD
Cohort 1/Placebo
Cohort 1/LSALT TBD mg
Cohort 2/Placebo
Cohort 2/LSALT TBD mg
etc.


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Note that the nominal doses as planned in the protocol are listed above. However, should the actual doses differ from the planned nominal doses, the 
actual doses will be displayed in the appropriate tabulations.
For descriptive statistical representation, columns detailing Parameter/Visit/Timepoint/Statistics may be combined to ensure that all treatment groups 
can be displayed on the same page.
For singular columns that are represented over multiple pages (Visits), an additional column may be added to the output to reflect the by parameter 
detail across each page. In some cases a statement describing the continuation (e.g. System Organ Classes with multiple Preferred Terms) of a field can 
be added to the first row of a page to ensure clarity.
Due to the number of groups, it may not be possible to fit all groups on one page in some of the summary tables. Therefore, the summary tables will be 
split across multiple pages.
For results that are not applicable to a specified visit ‘N/A’ (Not Applicable) will be noted. As an example, changes from baseline will be noted as 
‘N/A’ for pre-baseline visits.
For the final production tables, the listing source for each table and figure will be displayed in the footer.


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Table 14.1.1.2
Enrolment and Disposition – SAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Intent-to-Treat Population
xx
xx
Safety Population
Pharmacokinetic Concentration Population
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Pharmacodynamic Parameters Population
xx (xx.x%)
xx (xx.x%)
Completed the Study
Yes
xx (xx.x%)
xx (xx.x%)
No
xx (xx.x%)
xx (xx.x%)
Primary Reason For Eary Discontinuation
Adverse Event
xx (xx.x%)
xx (xx.x%)
Protocol Violation
xx (xx.x%)
xx (xx.x%)
Withdrawal of Consent
xx (xx.x%)
xx (xx.x%)
Death
xx (xx.x%)
xx (xx.x%)
Lost to Follow-Up
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)


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Table 14.1.1.3
Enrolment and Disposition – MAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Intent-to-Treat Population
xx
xx
Safety Population
Pharmacokinetic Population
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Pharmacodynamic Population
xx (xx.x%)
xx (xx.x%)
Completed the Study
Yes
xx (xx.x%)
xx (xx.x%)
No
xx (xx.x%)
xx (xx.x%)
Primary Reason For Eary Discontinuation
Adverse Event
xx (xx.x%)
xx (xx.x%)
Protocol Violation
xx (xx.x%)
xx (xx.x%)
Withdrawal of Consent
xx (xx.x%)
xx (xx.x%)
Death
xx (xx.x%)
xx (xx.x%)
Lost to Follow-Up
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)


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Table 14.1.2.2
Demographic Characteristics – SAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Gender
Male
xx (xx.x%)
xx (xx.x%)
Female
xx (xx.x%)
xx (xx.x%)
Child Bearing Potential
Yes
xx (xx.x%)
xx (xx.x%)
No
xx (xx.x%)
xx (xx.x%)
Post-menopausal
xx (xx.x%)
xx (xx.x%)
Surgically sterile
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)
Race
Asian
xx (xx.x%)
xx (xx.x%)
Black
xx (xx.x%)
xx (xx.x%)
White
xx (xx.x%)
xx (xx.x%)
Pacific Islander
xx (xx.x%)
xx (xx.x%)
Australian Aborigine/Torres Strait Islander
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)
Ethnicity
Hispanic or Latino
xx (xx.x%)
xx (xx.x%)
Not Hispanic or Latino
xx (xx.x%)
xx (xx.x%)
[1] Age (years) = integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25).
[2] BMI = Body Weight, in kg / ((Height, in m)2).
Note: For the child bearing potential summary, percentages will be based on number of females.
Note: For the child bearing potential summary, subcategory percentages will be based on number subjects within the corresponding category. 
Programming Note: Also include a Total column.


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Table 14.1.2.2
Demographic Characteristics – SAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Age (years)[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Height (cm)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Body Weight (kg)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
BMI (kg/m2)[2]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Age (years) = integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25).
[2] BMI = Body Weight, in kg / ((Height, in m)2).
Note: For the child bearing potential summary, percentages will be based on number of females.
Note: For the child bearing potential summary, subcategory percentages will be based on number subjects within the corresponding category.
Programming Note: Also include a Total column.


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Table 14.1.2.3     Demographic Characteristics – MAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Gender
Male
xx (xx.x%)
xx (xx.x%)
Female
xx (xx.x%)
xx (xx.x%)
Child Bearing Potential
Yes
xx (xx.x%)
xx (xx.x%)
No
xx (xx.x%)
xx (xx.x%)
Post-menopausal
xx (xx.x%)
xx (xx.x%)
Surgically sterile
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)
Race
Asian
xx (xx.x%)
xx (xx.x%)
Black
xx (xx.x%)
xx (xx.x%)
White
xx (xx.x%)
xx (xx.x%)
Pacific Islander
xx (xx.x%)
xx (xx.x%)
Australian Aborigine/Torres Strait Islander
xx (xx.x%)
xx (xx.x%)
Other
xx (xx.x%)
xx (xx.x%)
Ethnicity
Hispanic or Latino
xx (xx.x%)
xx (xx.x%)
Not Hispanic or Latino
xx (xx.x%)
xx (xx.x%)
[1] Age (years) = integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25).
[2] BMI = Body Weight, in kg / ((Height, in m)2).
Note: For the child bearing potential summary, percentages will be based on number of females.
Note: For the child bearing potential summary, subcategory percentages will be based on number subjects within the corresponding category. 
Programming Note: Also include a Total column.


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Table 14.1.2.3
Demographic Characteristics – MAD (Intent-to-Treat Population) 
All Placebo
etc.
(N=xxx)
(N=xxx)
Age (years)[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Height (cm)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Body Weight (kg)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
BMI (kg/m2)[2]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Age (years) = integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25).
[2] BMI = Body Weight, in kg / ((Height, in m)2).
Note: For the child bearing potential summary, percentages will be based on number of females.
Note: For the child bearing potential summary, subcategory percentages will be based on number subjects within the corresponding category.
Programming Note: Also include a Total column.


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Table 14.1.3.2
Concomitant Medications – SAD (Safety Population) 
ATC2 Class
Preferred Term
All Placebo
etc.
(N=xxx)
(N=xxx)
Subjects with at Least One Concomitant Medication
xx (xx.x%)
xx (xx.x%)
ATC2 A 
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 1
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 2
xx (xx.x%)
xx (xx.x%)
ATC2 B 
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 1
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 2
xx (xx.x%)
xx (xx.x%)
etc.
Concomitant medications coded using WHO Drug Version X.X.
Concomitant medications are medications taken at least once on or after first study drug administration.  Medications stopping on the same day as study
drug administration are considered as concomitant medications.
ATC = Anatomic Therapeutic Chemical, WHO DD = World Health Organization Drug Dictionary (WHO DD) Version.


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Table 14.1.3.3
Concomitant Medications – MAD (Safety Population) 
ATC2 Class 
Preferred Term
All Placebo
etc.
(N=xxx)
(N=xxx)
Subjects with at Least One Concomitant Medication
xx (xx.x%)
xx (xx.x%)
ATC2 A 
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 1
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 2
xx (xx.x%)
xx (xx.x%)
ATC2 B 
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 1
xx (xx.x%)
xx (xx.x%)
Preferred Drug Name 2
xx (xx.x%)
xx (xx.x%)
etc.
Concomitant medications coded using WHO Drug Version X.X.
Concomitant medications are medications taken at least once on or after first study drug administration.  Medications stopping on the same day as study
drug administration are considered as concomitant medications.
ATC = Anatomic Therapeutic Chemical, WHO DD = World Health Organization Drug Dictionary (WHO DD) Version.


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Table 14.1.4.3
Exposure – MAD (Safety Population) 
Administered Dose
All Placebo
etc.
(N=xxx)
(N=xxx)
Day 1 Dose
xx (xx.x%)
xx (xx.x%)
Day 2 Dose
xx (xx.x%)
xx (xx.x%)
Day 3 Dose
xx (xx.x%)
xx (xx.x%)
Programming Note: Also include a Total column.


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Table 14.2.1.1.1.2
Plasma Pharmacokinetic Concentrations – SAD (Pharmacokinetic Concentration Population)
Concentration (unit)
Visit
Scheduled Timepoint
LSALT 1.0 mg
(N=xxx)
etc.
(N=xxx)
Concentration (unit)
Day 1
XX Hours Pre-dose
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Geometric Mean
CV% Geometric Mean
xx.xx
xx.xxx
xx.xx
xx.xxx
etc.
Programming Note: Continue for all protocol scheduled visits/timepoints. 


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Table 14.2.1.1.1.3
Plasma Pharmacokinetic Concentrations – MAD (Pharmacokinetic Concentration Population)
Concentration (unit)
Visit
Scheduled Timepoint
LSALT XX mg
(N=xxx)
etc.
(N=xxx)
Concentration (unit)
Day 1
XX Hours Pre-dose
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Geometric Mean
CV% Geometric Mean
xx.xx
xx.xxx
xx.xx
xx.xxx
etc.
Programming Note: Continue for all protocol scheduled visits/timepoints.


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Figure 14.2.1.1.2.2
Individual Plasma Pharmacokinetic Concentrations by Treatment Group – SAD (Pharmacokinetic Concentration Population)
Plots of individual plasma concentrations over time, by treatment group for each subject
Figure Description: The individual plasma concentration over time will be presented, by treatment group for each subject. The figure will display on a 
single page values for all subjects within each treatment group. Straight lines will connect the values for each subject. Different symbols and line 
types will be used to distinguish between each subject.
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.2.3
Individual Plasma Pharmacokinetic Concentrations by Treatment Group – MAD (Pharmacokinetic Concentration Population)
Plots of individual plasma concentrations over time, by treatment group for each subject
Figure Description: The individual plasma concentration over time will be presented, by treatment group (including days 1 and 3 on juxtaposed figures) 
for each subject. The figure will display on a single page values for all subjects within each treatment group. Straight lines will connect the values 
for each subject. Different symbols and line types will be used to distinguish between each subject.
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.3.2
Individual Plasma Pharmacokinetic Concentrations (Log-Scale) by Treatment Group – SAD (Pharmacokinetic Concentration
Population)
Plots of individual plasma concentrations (log-scale) over time, by treatment group for each subject
Figure Description: The individual plasma concentration (log-scale) over time will be presented, by treatment group and visit for each subject. The 
figure will display on a single page values for all subjects within each treatment group. Straight lines will connect the values for each subject.
Different symbols and line types will be used to distinguish between each subject.
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.3.3
Individual Plasma Pharmacokinetic Concentrations (Log-Scale) by Treatment Group – MAD (Pharmacokinetic Concentration
Population)
Plots of individual plasma concentrations (log-scale) over time, by treatment group for each subject
Figure Description: The individual plasma concentration (log-scale) over time will be presented, by treatment group (including days 1 and 3 on
juxtaposed figures) for each subject. The figure will display on a single page values for all subjects within each treatment group. Straight lines will 
connect the values for each subject. Different symbols and line types will be used to distinguish between each subject.
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.4.2
Mean Plasma Pharmacokinetic Concentrations – SAD (Pharmacokinetic Concentration Population)
Plot of mean plasma concentrations over time 
Figure Description: The mean plasma concentration over time (±SD) will be presented. The figure will display on a single page values for all treatment
groups. Straight lines will connect the values within each treatment group. Different symbols and line types will be used to distinguish between each 
treatment group. The SD at each point will be added.
For each figure, the X axis will be the scheduled timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.4.3
Mean Plasma Pharmacokinetic Concentrations – MAD (Pharmacokinetic Concentration Population)
Plot of mean plasma concentrations over time
Figure Description: The mean plasma concentration over time (±SD) will be presented (including days 1 and 3 overlayed). The figure will display on a 
single page values for all treatment groups. Straight lines will connect the values within each treatment group. Different symbols and line types will 
be used to distinguish between each treatment group. The SD at each point will be added.
For each figure, the X axis will be the scheduled timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.5.2
Mean Plasma Pharmacokinetic Concentrations (Log-Scale) – SAD (Pharmacokinetic Concentration Population)
Plot of mean plasma concentrations (log-scale) over time
Figure Description: The mean plasma concentration (log-scale) over time will be presented. The figure will display on a single page values for all
treatment groups. Straight lines will connect the values within each treatment group. Different symbols and line types will be used to distinguish 
between each treatment group. 
For each figure, the X axis will be the scheduled timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Figure 14.2.1.1.5.3
Mean Plasma Pharmacokinetic Concentrations (Log-Scale) – MAD (Pharmacokinetic Concentration Population)
Plot of mean plasma concentrations (log-scale) over time
Figure Description: The mean plasma concentration (log-scale) over time will be presented (including days 1 and 3 overlayed). The figure will display on 
a single page values for all treatment groups (including days 1 and 7 overlayed). Straight lines will connect the values within each treatment group.
Different symbols and line types will be used to distinguish between each treatment group. 
For each figure, the X axis will be the scheduled timepoint. The Y axis will be the concentration, in units.
The X axis title: Timepoint
The Y axis title: Concentration (units)


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Table 14.2.1.2.1.2
Plasma Pharmacokinetic Parameters – SAD (Pharmacokinetic Parameters Population)
Parameter (unit)
LSALT 1.0 mg
(N=xxx)
etc.
(N=xxx)
AUC0-t (unit)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Geometric Mean
CV% Geometric Mean
xx.xx
xx.xxx
xx.xx
xx.xxx
etc.
Programming Note: Continue for all plasma pharmacokinetic parameters.


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Table 14.2.1.2.1.3
Plasma Pharmacokinetic Parameters – MAD (Pharmacokinetic Parameters Population)
Day 1 Plasma PK Parameters
Parameter (unit)
LSALT XX mg
(N=xxx)
etc.
(N=xxx)
AUC0-t (unit)
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Geometric Mean
CV% Geometric Mean
xx.xx
xx.xxx
xx.xx
xx.xxx
etc.
Programming Note: Continue for all plasma pharmacokinetic parameters, and Day 7 PK Parameters


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Table 14.2.1.2.2.2
Analysis of Dose Proportionality – SAD (Pharmacokinetic Parameters Population)
Dose Levels 
Included
Number of Subjects
Included in the Analysis
Power Model Analysis
PK Parameter (unit)
Slope
Estimate
90% CI for the 
Slope
Interval
Criterion
Criterion
Satisfied[1]
XX mg, XX mg, XX mg
AUC0-t (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
Yes
AUC0-inf (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
Yes
Cmax (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
No
[1] If the reported 90% confidence interval is entirely contained within the interval criterion of (0.xxx, 1.xxx), then dose proportionality is 
supported across the investigated dose range. 


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Table 14.2.1.2.2.3     Analysis of Dose Proportionality – SAD (Pharmacokinetic Parameters Population)
Day 1 PK Parameters
Dose Levels 
Included
Number of Subjects
Included in the Analysis
Power Model Analysis
PK Parameter (unit)
Slope
Estimate
90% CI for the 
Slope
Interval
Criterion
Criterion
Satisfied[1]
XX mg, XX mg, XX mg
AUC0-t (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
Yes
AUC0-inf (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
Yes
Cmax (unit)
xx
xx.xxx
(xx.xxx, xx.xxx)
(0.xxx, 1.xxx)
No
etc.
[1] If the reported 90% confidence interval is entirely contained within the interval criterion of (0.xxx, 1.xxx), then dose proportionality is 
supported across the investigated dose range, for the particular dosing regimen.


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Figure 14.2.1.2.3.2
Estimated Pharmacokinetic Parameters (Power Model) – SAD (Pharmacokinetic Parameters Population)
Plot of estimated PK parameters against dose level
Figure Description: PK parameters, as estimated from the power model, will be plotted against dose (mg). The figure will include individual subject
values and the means(±SD) for each dose level. The figure will display on a single page values for all dose levels, and all individual subjects.
For each figure, the X axis will be the dose level. The Y axis will be the PK parameter, in units.
The X axis title: Dose (mg)
The Y axis title: PK Parameter (unit)


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Figure 14.2.1.2.3.3
Estimated Pharmacokinetic Parameters (Power Model) – SAD (Pharmacokinetic Parameters Population)
Plot of estimated PK parameters against dose level
Figure Description: PK parameters, as estimated from the power model, will be plotted against dose (mg). The figure will include individual subject 
values and the means(±SD) for each dose level. The figure will display on a single page values for all dose levels, and all individual subjects.
For each figure, the X axis will be the dose level. The Y axis will be the PK parameter, in units.
The X axis title: Dose (mg)
The Y axis title: PK Parameter (unit)


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Table 14.3.1.1.2
Treatment Emergent Adverse Events Overall Summary – SAD (Safety Population)
All Placebo
LSALT 1.0 mg
etc.
(N=xxx)
S(%)E
(N=xxx)
S(%)E
(N=xxx)
S(%)E
At Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Severe or Life-threatening TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Study Drug-related[1] TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Serious TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Serious Study Drug-related[1] TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Discontinuation Due to TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Death
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
[1] Drug-related is defined as Missing, Possibly, Probably or Related. 


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Table 14.3.1.1.3
Treatment Emergent Adverse Events Overall Summary – MAD (Safety Population)
All Placebo
LSALT XX mg
etc.
(N=xxx)
S(%)E
(N=xxx)
S(%)E
(N=xxx)
S(%)E
At Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Severe or Life-threatening TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Study Drug-related[1] TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Serious TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
At Least One Serious Study Drug-related[1] TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Discontinuation Due to TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Death
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
[1] Drug-related is defined as Missing, Possibly, Probably or Related.


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Table 14.3.1.2.2
Treatment Emergent Adverse Events – SAD (Safety Population)
System Organ Class
Preferred Term
All Placebo
LSALT 1.0 mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.2.3
Treatment Emergent Adverse Events – MAD (Safety Population)
System Organ Class
Preferred Term
All Placebo
LSALT XX mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at least one TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.3.2
Treatment Emergent Adverse Events by Severity – SAD (Safety Population)
System Organ Class
Preferred Term
Severity
All Placebo
LSALT 1.0 mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Mild
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Moderate
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Severe
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Life-threatening consequences
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Mild
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Moderate
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Severe
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Life-threatening consequences
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.3.3
Treatment Emergent Adverse Events by Severity – MAD (Safety Population)
System Organ Class
Preferred Term
Severity
All Placebo
LSALT XX mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Mild
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Moderate
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Severe
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Life-threatening consequences
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Mild
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Moderate
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Severe
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Life-threatening consequences
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.4.2
Treatment Emergent Adverse Events by Relationship to Study Drug – SAD (Safety Population)
System Organ Class
Preferred Term
Relationship to Study Drug
All Placebo
LSALT 1.0 mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unrelated
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unlikely Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Possibly Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Probably Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unrelated
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unlikely Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Possibly Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Probably Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.4.3
Treatment Emergent Adverse Events by Relationship to Study Drug – MAD (Safety Population)
System Organ Class
Preferred Term
Relationship to Study Drug
All Placebo
LSALT XX mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unrelated
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unlikely Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Possibly Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Probably Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unrelated
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Unlikely Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Possibly Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Probably Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Related
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Missing
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.5.2
Serious Treatment Emergent Adverse Events – SAD (Safety Population)
System Organ Class
Preferred Term
All Placebo
LSALT 1.0 mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One Serious TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.1.5.3
Serious Treatment Emergent Adverse Events – MAD (Safety Population)
System Organ Class
Preferred Term
All Placebo
LSALT XX mg
etc.
(N=xxx)
(N=xxx)
(N=xxx)
S (%) E
S (%) E
S (%) E
Subjects with at Least One Serious TEAE
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
System Organ Class 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 1
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
Preferred Term 2
xx (xx.x%) xx
xx (xx.x%) xx
xx (xx.x%) xx
etc.
S = Subjects, E = Events.
TEAE = Treatment Emergent Adverse Event.
Note: Subjects are counted once if the same event occurred more than one time.
Note: This table presents the number of subjects with an event, the percentage of total subjects with an event and the number of events. Percentages are 
based on the total number of treated subjects.
Note: Adverse events coded according to MedDRA Version XX.


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Table 14.3.4.1.1.2
Hematology – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Hemoglobin (g/L)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 


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Table 14.3.4.1.1.2
Hematology – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Hemoglobin (g/L)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all hematology parameters.


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Table 14.3.4.1.1.3
Hematology – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Hemoglobin (g/L)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Table 14.3.4.1.1.3
Hematology – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Hemoglobin (g/L)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all hematology parameters.


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Table 14.3.4.1.2.2
Hematology Shifts From Baseline – SAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
Hemoglobin (g/L)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all hematology parameters.


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Table 14.3.4.1.2.3
Hematology Shifts From Baseline – MAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
Hemoglobin (g/L)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all hematology parameters.


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Table 14.3.4.1.3.2
Chemistry – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Albumin (g/L)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Table 14.3.4.1.3.2
Chemistry – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Albumin (g/L)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all chemistry parameters.


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Table 14.3.4.1.3.3
Chemistry – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Albumin (g/L)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Table 14.3.4.1.3.3
Chemistry – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
Albumin (g/L)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all chemistry parameters.


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Table 14.3.4.1.4.2
Chemistry Shifts From Baseline – SAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
Albumin (g/L)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all chemistry parameters.


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Table 14.3.4.1.4.3
Chemistry Shifts From Baseline – MAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
Albumin (g/L)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all chemistry parameters.


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Table 14.3.4.1.3.2
Coagulation – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
INR (unit)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Table 14.3.4.1.5.2     Coagulation – SAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
INR (unit)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all chemistry parameters.


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Table 14.3.4.1.5.3
Coagulation – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
INR (unit)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Table 14.3.4.1.5.3
Coagulation – MAD (Safety Population)
Parameter (unit)
Visit
All Placebo
(N=xxx)
etc.
(N=xxx)
INR (unit)
Day XX
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all chemistry parameters.


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Table 14.3.4.1.6.2
Coagulation Shifts From Baseline – SAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
INR (unit)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all chemistry parameters.


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Table 14.3.4.1.6.3
Coagulation Shifts From Baseline – MAD (Safety Population)
Treatment Group: All Placebo (N=xxx)
Parameter (unit)
Visit
Baseline[1]
Post Baseline[1]
Normal
Abnormal NCS
Abnormal CS
Missing
INR (unit)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Day XX
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
NCS = Not Clinically Signifcant, CS = Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/time points and all chemistry parameters.


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Table 14.3.4.1.7.2
Urinalysis Results Evaluation – SAD (Safety Population)
Parameter (unit)
Visit
Result
All Placebo
etc.
(N=xxx)
(N=xxx)
Glucose (mmol/L)
Baseline[1]
Positive
xx (xx.x%)
xx (xx.x%)
Negative
xx (xx.x%)
xx (xx.x%)
Day XX
Positive
xx (xx.x%)
xx (xx.x%)
Negative
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all urinalysis parameters.


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Table 14.3.4.1.7.3
Urinalysis Results Evaluation – MAD (Safety Population)
Parameter (unit)
Visit
Result
All Placebo
etc.
(N=xxx)
(N=xxx)
Glucose (mmol/L)
Baseline[1]
Positive
xx (xx.x%)
xx (xx.x%)
Negative
xx (xx.x%)
xx (xx.x%)
Day XX
Positive
xx (xx.x%)
xx (xx.x%)
Negative
xx (xx.x%)
xx (xx.x%)
etc.
[1] Baseline is defined as the last available, non-missing assessment prior to first study drug administration. 
Programming Note: Continue for all protocol scheduled visits and all urinalysis parameters.


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Table 14.3.4.2.1.2
Vital Signs – SAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
Pulse Rate (beats/min)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 


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Page 101 of 192
Table 14.3.4.2.1.2
Vital Signs – SAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
Pulse Rate (beats/min)
Day XX
XX hours postdose
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all scheduled visits/timepoints and all vital signs parameters. 


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Table 14.3.4.2.1.3
Vital Signs – MAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
Pulse Rate (beats/min)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 


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Table 14.3.4.2.1.3
Vital Signs – MAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
Pulse Rate (beats/min)
Day XX
XX hours postdose
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
Programming Note: Continue for all scheduled visits/timepoints and all vital signs parameters. 


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Table 14.3.4.2.2.2     Vital Signs Shifts from Baseline – SAD (Safety Population)
Treatment Group: All Placebo
Parameter
(unit)
Baseline[1]
Post Baseline[1]
Visit
Scheduled
Timepoint
Normal
Abnormal NCS
Abnormal CS
Missing
Pulse Rate 
Day XX
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
(beats/min)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
NCS=Not Clinically Significant, CS=Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/timepoints, readings and all groups.


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Table 14.3.4.2.2.3
Vital Signs Shifts from Baseline – MAD (Safety Population)
Treatment Group: All Placebo
Parameter
(unit)
Baseline[1]
Post Baseline[1]
Visit
Scheduled
Timepoint
Normal
Abnormal NCS
Abnormal CS
Missing
Pulse Rate 
Day XX
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
(beats/min)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
NCS=Not Clinically Significant, CS=Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/timepoints, readings and all groups.


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Page 106 of 192
Table 14.3.4.3.1.2
12-Lead Electrocardiogram – SAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
RR Interval (msec)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Page 107 of 192
Table 14.3.4.3.1.2
12-Lead Electrocardiogram – SAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
RR Interval (msec)
Day XX
XX Hours Postdose
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
Programming Note: Continue for all scheduled visits/timepoints, readings and all ECG parameters.


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Page 108 of 192
Table 14.3.4.3.1.3
12-Lead Electrocardiogram – MAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
RR Interval (msec)
Baseline[1]
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.


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Page 109 of 192
Table 14.3.4.3.1.3
12-Lead Electrocardiogram – MAD (Safety Population)
Parameter (unit)
Visit
Scheduled Timepoint
All Placebo
etc.
(N=xxx)
(N=xxx)
RR Interval (msec)
Day XX
XX Hours Postdose
Actual Value
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
Actual Change from Baseline[1]
n
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
etc.
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
Programming Note: Continue for all scheduled visits/timepoints, readings and all ECG parameters.


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Page 110 of 192
Table 14.3.4.3.2.2
12-Lead Electrocardiogram Shifts from Baseline – SAD (Safety Population)
Treatment Group: All Placebo
Parameter
(unit)
Baseline[1]
Post Baseline[1]
Visit
Scheduled
Timepoint
Normal
Abnormal NCS
Abnormal CS
Missing
RR Interval 
Day XX
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
(msec)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
NCS=Not Clinically Significant, CS=Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/timepoints, readings and all groups.


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Page 111 of 192
Table 14.3.4.3.2.3
12-Lead Electrocardiogram Shifts from Baseline – MAD (Safety Population)
Treatment Group: All Placebo
Parameter
(unit)
Baseline[1]
Post Baseline[1]
Visit
Scheduled
Timepoint
Normal
Abnormal NCS
Abnormal CS
Missing
RR Interval 
Day XX
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
(msec)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
XX hours
Normal
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
postdose
Abnormal NCS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Abnormal CS
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
Missing
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
xx (xx.x%)
[1] Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
NCS=Not Clinically Significant, CS=Clinically Significant.
Programming Note: Continue for all protocol scheduled visits/timepoints, readings and all groups.


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Page 112 of 192
Table 14.3.4.4.1.3
Anti-Drug Antibodies – MAD (Safety Population)
Parameter (unit)
Visit
Result
All Placebo
etc.
(N=xxx)
(N=xxx)
ADA
Day 14
Positive
xx (xx.x%)
xx (xx.x%)
Negative
xx (xx.x%)
xx (xx.x%)
etc.


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Page 113 of 192
Listing 16.2.1.1.1     Subject Enrollment – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Date of
Informed
Consent
Informed
Consent
Version
Protocol
Version
Date/ Time of  
Study Drug 
Administration
Included in
Intent-to-Treat
Population
Included in
Safety
Population
Included in
Pharmacokinetic
Concentration
Population
Included in
Pharmacokinetic
Parameters
Population
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
etc.


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Page 114 of 192
Listing 16.2.1.1.2     Subject Enrollment – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date of
Informed
Consent
Informed
Consent
Version
Protocol
Version
Date/ Time of  
Study Drug 
Administration
Included in
Intent-to-Treat
Population
Included in
Safety
Population
Included in
Pharmacokinetic
Concentration
Population
Included in
Pharmacokinetic
Parameters
Population
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
etc.


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Page 115 of 192
Listing 16.2.1.1.3
Subject Enrollment – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date of
Informed
Consent
Informed
Consent
Version
Protocol
Version
Date/ Time of First
Study Drug 
Administration
Included in
Intent-to-Treat
Population
Included in
Safety
Population
Included in
Pharmacokinetic
Concentration
Population
Included in
Pharmacokinetic
Parameters
Population
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
xxxxx
DDMONYYYY
x
x
DDMONYYYY/ HH:MM
Yes
Yes
Yes
Yes
etc.


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Page 116 of 192
Listing 16.2.1.2.1     Subject Disposition – Low Dose (Intent-to-Treat Population) 
Treatment Group: LSALT 0.01 mg
Subject Number
Subject Completed the Study per
Protocol
Date of Completion or Early 
Discontinuation
Primary Reason for Early Discontinuation/ If AE, Number
xxxxx
No
DDMONYYYY
Withdrawal of Consent


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Protocol: AB001
Page 117 of 192
Listing 16.2.1.2.2     Subject Disposition - SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject Number
Subject Completed the Study per
Protocol
Date of Completion or Early 
Discontinuation
Primary Reason for Early Discontinuation/ If AE, Number
xxxxx
No
DDMONYYYY
Withdrawal of Consent
xxxxx
Yes
DDMONYYYY
xxxxx
No
DDMONYYYY
Other - xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
etc.


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Protocol: AB001
Page 118 of 192
Listing 16.2.1.2.3
Subject Disposition – MAD (Intent-to-Treat Population) 
Cohort/Treatment Group: Cohort 4/Placebo
Subject Number
Subject Completed the Study per
Protocol
Date of Completion or Early 
Discontinuation
Primary Reason for Early Discontinuation/ If AE, Number
xxxxx
No
DDMONYYYY
Withdrawal of Consent
xxxxx
Yes
DDMONYYYY
xxxxx
No
DDMONYYYY
Other - xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
etc.


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Page 119 of 192
Listing 16.2.2.1     Protocol Deviations – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Date of Deviation
Deviation Category
Assessment Type
Protocol Deviation 
Classification
Deviation Description
xxxxx
Screening
DDMONYYYY
Missed Visit
Medical History
Minor
xxxxxxxxxxxxxxxxxx
Day 1
DDMONYYYY
Other - xxxxxxxxxx
Demographics
Major
xxxxxxxxxxxxxxxxxx
etc.
etc.
etc.
etc.
etc.
Note: The form of this listing may change depending upon the data collected for protocol deviations. 


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Protocol: AB001
Page 120 of 192
Listing 16.2.2.2
Protocol Deviations – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Date of Deviation
Deviation Category
Assessment Type
Protocol Deviation 
Classification
Deviation Description
xxxxx
Screening
DDMONYYYY
Missed Visit
Medical History
Minor
xxxxxxxxxxxxxxxxxx
Day 1
DDMONYYYY
Other - xxxxxxxxxx
Demographics
Major
xxxxxxxxxxxxxxxxxx
etc.
etc.
etc.
etc.
etc.
etc.
Note: The form of this listing may change depending upon the data collected for protocol deviations.


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Protocol: AB001
Page 121 of 192
Listing 16.2.2.3
Protocol Deviations – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Date of Deviation
Deviation Category
Assessment Type
Protocol Deviation 
Classification
Deviation Description
xxxxx
Screening
DDMONYYYY
Missed Visit
Medical History
Minor
xxxxxxxxxxxxxxxxxx
Day 1
DDMONYYYY
Other - xxxxxxxxxx
Demographics
Major
xxxxxxxxxxxxxxxxxx
etc.
etc.
etc.
etc.
etc.
etc.
Note: The form of this listing may change depending upon the data collected for protocol deviations.


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Protocol: AB001
Page 122 of 192
Lising 16.2.3.1.1
Eligibility Criteria – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject Number
Visit
Subject Met All Eligibility Criteria/ If No, 
Criteria Not Met
If Eligibilty Not Met, Exemption Granted
xxxxx
Screening
Day -1
Yes
No/ Inclusion - 1
No


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Protocol: AB001
Page 123 of 192
Lising 16.2.3.1.2
Eligibility Criteria – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject Number
Visit
Subject Met All Eligibility Criteria/ If No, 
Criteria Not Met
If Eligibilty Not Met, Exemption Granted
xxxxx
Screening
Day -1
Yes
No/ Inclusion - 1
No
etc.


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Protocol: AB001
Page 124 of 192
Lising 16.2.3.1.3
Eligibility Criteria – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject Number
Visit
Subject Met All Eligibility Criteria/ If No, 
Criteria Not Met
If Eligibilty Not Met, Exemption Granted
xxxxx
Screening
Day -1
Yes
No/ Inclusion - 1
No
etc.


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Protocol: AB001
Page 125 of 192
Listing 16.2.4.1.1
Demographic Characteristics – Low Dose (Intent-to-Treat Population) 
Treatment Group: LSALT 0.01 mg
Subject
Number
Date of
Informed Consent
Date of
Birth
Age
(years)[1]
Gender
Child Bearing
Potential/ If 
No, Reason
Race
Ethnicity
Height (cm) at
Screening
Weight (kg) at
Screening
BMI (kg/m2)[2] at 
Screening
xxxxx
DDMONYYYY
DDMONYYYY
xx
Female
Yes
xxxxxxx
xxxxxxx
xx.x
xx.x
xx.x
[1] Age is calculated as integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25) 
[2] BMI = Body Weight, in kg/((Height, in m)2).


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Protocol: AB001
Page 126 of 192
Listing 16.2.4.1.2     Demographic Characteristics – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date of
Informed Consent
Date of
Birth
Age
(years)[1]
Gender
Child Bearing
Potential/ If 
No, Reason
Race
Ethnicity
Height (cm) at
Screening
Weight (kg) at
Screening
BMI (kg/m2)[2] at 
Screening
xxxxx
DDMONYYYY
DDMONYYYY
xx
Female
Yes
xxxxxxx
xxxxxxx
xx.x
xx.x
xx.x
xxxxx
DDMONYYYY
DDMONYYYY
xx
Male
N/A
xxxxxxx
xxxxxxx
xx.x
xx.x
xx.x
xxxxx
DDMONYYYY
DDMONYYYY
xx
Female
No
Other -
xxxxx
xxxxxxx
xx.x
xx.x
xx.x
etc.
[1] Age is calculated as integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25)
[2] BMI = Body Weight, in kg/((Height, in m)2).


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Protocol: AB001
Page 127 of 192
Listing 16.2.4.1.3
Demographic Characteristics – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date of
Informed Consent
Date of
Birth
Age
(years)[1]
Gender
Child Bearing
Potential/ If 
No, Reason
Race
Ethnicity
Height (cm) at
Screening
Weight (kg) at
Screening
BMI (kg/m2)[2] at 
Screening
xxxxx
DDMONYYYY
DDMONYYYY
xx
Female
Yes
xxxxxxx
xxxxxxx
xx.x
xx.x
xx.x
xxxxx
DDMONYYYY
DDMONYYYY
xx
Male
N/A
xxxxxxx
xxxxxxx
xx.x
xx.x
xx.x
xxxxx
DDMONYYYY
DDMONYYYY
xx
Female
No
Other -
xxxxx
xxxxxxx
xx.x
xx.x
xx.x
etc.
[1] Age is calculated as integer value ((Date Signed Informed Consent – Date of Birth + 1) / 365.25)
[2] BMI = Body Weight, in kg/((Height, in m)2).


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Protocol: AB001
Page 128 of 192
Listing 16.2.4.2.1
Medical History – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Medical Condition/ Surgery
Onset Date
End Date
xxxxx
xxxxxxxxxx
DDMONYYYY
Ongoing
xxxxxxxxxx
DDMONYYYY
DDMONYYYY
Note: Medications coded using MedDRA Version X.X. 


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Protocol: AB001
Page 129 of 192
Listing 16.2.4.2.2
Medical History – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Medical Condition/ Surgery
Onset Date
End Date
xxxxx
xxxxxxxxxx
DDMONYYYY
Ongoing
xxxxxxxxxx
DDMONYYYY
DDMONYYYY
xxxxx
xxxxxxxxxx
DDMONYYYY
DDMONYYYY
etc.
Note: Medications coded using MedDRA Version X.X.


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Protocol: AB001
Page 130 of 192
Listing 16.2.4.2.3
Medical History – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Medical Condition/ Surgery
Onset Date
End Date
xxxxx
xxxxxxxxxx
DDMONYYYY
Ongoing
xxxxxxxxxx
DDMONYYYY
DDMONYYYY
xxxxx
xxxxxxxxxx
DDMONYYYY
DDMONYYYY
etc.
Note: Medications coded using MedDRA Version X.X. 


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Protocol: AB001
Page 131 of 192
Listing 16.2.4.3.1
Alcohol Breath Test – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Test Performed/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
No/ xxxxxx


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Protocol: AB001
Page 132 of 192
Listing 16.2.4.3.2
Alcohol Breath Test – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Test Performed/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
No/ xxxxxx
etc.


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Protocol: AB001
Page 133 of 192
Listing 16.2.4.3.3
Alcohol Breath Test – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Test Performed/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
No/ xxxxxx
etc.


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Page 134 of 192
Listing 16.2.4.4.1
Urine Drug Screen – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Test Performed
Date/Time of Sample  Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
Yes
DDMONYYYY/ HH:MM
Positive


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Protocol: AB001
Page 135 of 192
Listing 16.2.4.4.2     Urine Drug Screen – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Test Performed
Date/Time of Sample  Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
Yes
DDMONYYYY/ HH:MM
Positive
xxxxx
Screening
No
Day -1
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Page 136 of 192
Listing 16.2.4.4.3
Urine Drug Screen – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Test Performed
Date/Time of Sample  Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
Day -1
Yes
DDMONYYYY/ HH:MM
Positive
xxxxx
Screening
No
Day -1
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Page 137 of 192
Listing 16.2.4.5.1
Serology – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Test
Sample Collected/ If No, Reason
Date/ Time of Sample 
Collection
Result
xxxxx
Screening
HIV Type 1
Yes
DDMONYYYY/ HH:MM
Negative
HIV Type 2
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis B 
surface antigen
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis C
surface antibody
Yes
DDMONYYYY/ HH:MM
Negative


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Protocol: AB001
Page 138 of 192
Listing 16.2.4.5.2     Serology – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Test
Sample Collected/ If No, Reason
Date/ Time of Sample 
Collection
Result
xxxxx
Screening
HIV Type 1
Yes
DDMONYYYY/ HH:MM
Negative
HIV Type 2
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis B 
surface antigen
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis C
surface antibody
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Protocol: AB001
Page 139 of 192
Listing 16.2.4.5.3
Serology – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Test
Sample Collected/ If No, Reason
Date/ Time of Sample 
Collection
Result
xxxxx
Screening
HIV Type 1
Yes
DDMONYYYY/ HH:MM
Negative
HIV Type 2
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis B 
surface antigen
Yes
DDMONYYYY/ HH:MM
Negative
Hepatitis C
surface antibody
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Listing 16.2.4.6.1     Serum Follicle Stimulating Hormone – Low Dose (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Sample Collected/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative


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Listing 16.2.4.6.2     Serum Follicle Stimulating Hormone – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Sample Collected/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Listing 16.2.4.6.3
Serum Follicle Stimulating Hormone – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Sample Collected/ If No, Reason
Date/ Time of Sample Collection
Result
xxxxx
Screening
Yes
DDMONYYYY/ HH:MM
Negative
etc.


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Listing 16.2.4.7.1     Pregnancy – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Panel
Test Performed/ If No, 
Reason
Date/Time of Sample
Collection
Result
xxxxx
Screening
Urine
Yes
DDMONYYYY/ HH:MM
Negative
Serum
Yes
DDMONYYYY/ HH:MM
Positive
etc.


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Listing 16.2.4.7.2
Pregnancy – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Panel
Test Performed/ If No, 
Reason
Date/Time of Sample
Collection
Result
xxxxx
Screening
Urine
Yes
DDMONYYYY/ HH:MM
Negative
Serum
Yes
DDMONYYYY/ HH:MM
Positive
etc.
etc.


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Listing 16.2.4.7.3
Pregnancy – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Panel
Test Performed/ If No, 
Reason
Date/Time of Sample
Collection
Result
xxxxx
Screening
Urine
Yes
DDMONYYYY/ HH:MM
Negative
Serum
Yes
DDMONYYYY/ HH:MM
Positive
etc.
etc.


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Page 146 of 192
Listing 16.2.4.8.1     Prior and Concomitant Medications – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Date/ Time of
Study Drug 
Administrtation
ATC2 Class/
Preferred Term/
Medication
Indication/ If 
Adverse Event or
Medical History, 
Specify
Dose/
Unit
Frequency
Route
Start Date/ 
Study Day
End Date/ 
Study Day
Prior or
Concomitant
xxxxx
DDMONYYYY/ HH:MM
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
1000 mg
QD
Oral
DDMONYYYY/
XX
DDMONYYYY/ XX
Prior
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx/
yyyyyyyyyyyyyyy
10 mg
BID
Oral
DDMONYYYY/
XX
Ongoing
Concomitant
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
100 mg
QID
Other –
xxxxxx
DDMONYYYY/
XX
DDMONYYYY/ XX
Concomitant
Prior and concomitant medications coded using WHO Drug Version X.X.
Concomitant medications are medications taken at least once on or after first study drug administration. Prior medications are medications stopped prior
to first study drug administration. Medications stopping on the same day as first study drug administration are considered as concomitant medications.
ATC = Anatomic Therapeutic Chemical, WHO DD = World Health Organization Drug (WHO DD) Version.


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Listing 16.2.4.8.2
Prior and Concomitant Medications – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date/ Time of
Study Drug 
Administrtation
ATC2 Class/
Preferred Term/
Medication
Indication/ If 
Adverse Event or
Medical History, 
Specify
Dose/
Unit
Frequency
Route
Start Date/ 
Study Day
End Date/ 
Study Day
Prior or
Concomitant
xxxxx
DDMONYYYY/ HH:MM
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
1000 mg
QD
Oral
DDMONYYYY/
XX
DDMONYYYY/ XX
Prior
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx/
yyyyyyyyyyyyyyy
10 mg
BID
Oral
DDMONYYYY/
XX
Ongoing
Concomitant
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
100 mg
QID
Other –
xxxxxx
DDMONYYYY/
XX
DDMONYYYY/ XX
Concomitant
etc.
Prior and concomitant medications coded using WHO Drug Version X.X.
Concomitant medications are medications taken at least once on or after first study drug administration. Prior medications are medications stopped prior
to first study drug administration. Medications stopping on the same day as first study drug administration are considered as concomitant medications.
ATC = Anatomic Therapeutic Chemical, WHO DD = World Health Organization Drug (WHO DD) Version.


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Listing 16.2.4.9.3
Prior and Concomitant Medications – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date/ Time of
Study Drug 
Administrtation
ATC2 Class/
Preferred Term/
Medication
Indication/ If 
Adverse Event or
Medical History, 
Specify
Dose/
Unit
Frequency
Route
Start Date/ 
Study Day
End Date/ 
Study Day
Prior or
Concomitant
xxxxx
DDMONYYYY/ HH:MM
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
1000 mg
QD
Oral
DDMONYYYY/
XX
DDMONYYYY/ XX
Prior
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx/
yyyyyyyyyyyyyyy
10 mg
BID
Oral
DDMONYYYY/
XX
Ongoing
Concomitant
ZZZZZZZZZZZZZZ/
XXXXXXXXXXXXXX/
YYYYYYYYYYYYYYY
xxxxxxxxxxxxxxx
100 mg
QID
Other –
xxxxxx
DDMONYYYY/
XX
DDMONYYYY/ XX
Concomitant
etc.
Prior and concomitant medications coded using WHO Drug Version X.X.
Concomitant medications are medications taken at least once on or after first study drug administration. Prior medications are medications stopped prior
to first study drug administration. Medications stopping on the same day as first study drug administration are considered as concomitant medications.
ATC = Anatomic Therapeutic Chemical, WHO DD = World Health Organization Drug (WHO DD) Version.


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Listing 16.2.5.1.1
Study Drug Administration – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Study Drug
Administered/ If 
No, Reason
Administration Date/
Time
Dose Level (mg)
Volume Prepared 
(mL)
Total Volum 
Administered (mL) 
Infusion
Interrupted/ If 
Yes, Specify 
xxxxx
Day 1
Yes
DDMONYYYY/HH:MM
xx.xx
xxx
xxx
No


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Listing 16.2.5.1.2     Study Drug Administration – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Study Drug
Administered/ If 
No, Reason
Administration Date/
Time
Dose Level (mg)
Volume Prepared 
(mL)
Total Volum 
Administered (mL) 
Infusion
Interrupted/ If 
Yes, Specify 
xxxxx
Day 1
Yes
DDMONYYYY/HH:MM
xx.xx
xxx
xxx
No
etc.


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Page 151 of 192
Listing 16.2.5.1.3
Study Drug Administration – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Study Drug
Administered/ If 
No, Reason
Administration Date/
Time
Dose Level (mg)
Volume Prepared 
(mL)
Total Volum 
Administered (mL) 
Infusion
Interrupted/ If 
Yes, Specify 
xxxxx
Day 1
Yes
DDMONYYYY/HH:MM
xx.xx
xxx
xxx
No
Day 2
Yes
DDMONYYYY/HH:MM
xx.xx
xxx
xxx
No
etc.
etc.


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Listing 16.2.5.2.1
Randomization – Low Dose (Intent-to-Treat Population)
Subject
Number
Subject Eligible for 
Randomization
Randomization Date/ Time
Randomization
Number
Treatment Group
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
LSALT 0.01 mg
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
LSALT 0.1 mg
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
LSALT 0.3 mg
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
LSALT 0.5 mg


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Page 153 of 192
Listing 16.2.5.2.2
Randomization – SAD (Intent-to-Treat Population)
Subject
Number
Subject Eligible for 
Randomization
Randomization Date/ Time
Randomization
Number
Cohort: Treatment Group
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
Cohort 1: Placebo
etc.


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Page 154 of 192
Listing 16.2.5.2.3
Randomization – MAD (Intent-to-Treat Population)
Subject
Number
Subject Eligible for 
Randomization
Randomization Date/ Time
Randomization
Number
Cohort: Treatment Group
xxxxx
Yes
DDMONYYYY/ HH:MM
xxxxx
Cohort 4: Placebo
etc.


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Page 155 of 192
Listing 16.2.7.1.1     Adverse Events – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
No
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
Yes
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
Adverse Events coded using MedDRA Version X.X. 
[1] TEAE = Treatment Emergent Adverse Event.


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Page 156 of 192
Listing 16.2.7.1.2     Adverse Events – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
No
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
Yes
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
etc.
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Listing 16.2.7.1.3
Adverse Events – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
No
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
Yes
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
etc.
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 158 of 192
Listing 16.2.7.2.1     Serious Adverse Events – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Reason
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 159 of 192
Listing 16.2.7.2.2     Serious Adverse Events – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Reason
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
etc.
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 160 of 192
Listing 16.2.7.2.3     Serious Adverse Events – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ 
Class/
Preferred Term/
Adverse Event
SAE
Reason
Onset Date/ 
Time/
Study Day
Resolution
Date/ Time
Study Day
Severity
Relationship
to Study Drug
Outcome
Action Taken 
with Study 
Drug
Concomitant
Medication
Administered
TEAE[1]
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX 
Mild
Related
Recovering
/Resolving
Study Drug 
Stopped
No
Yes
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
xxxxxx
DDMONYYYY/
HH:MM/
XX
DDMONYYYY/
HH:MM/
XX
Moderate
Unrelated
Unknown
Unkown
Yes
Yes
etc.
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 161 of 192
Listing 16.2.7.3.1     Non-Treatment-Emergent Adverse Events – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ Class/
Preferred Term/
Adverse Event
Onset Date/ Time/
Study Day
Resolution Date/ 
Time
Study Day
Severity
Outcome
Concomitant
Medication
Administered
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Mild
Recovering/
Resolving
No
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Moderate
Unknown
Yes
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 162 of 192
Listing 16.2.7.3.2
Non-Treatment-Emergent Adverse Events – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ Class/
Preferred Term/
Adverse Event
Onset Date/ Time/
Study Day
Resolution Date/ 
Time
Study Day
Severity
Outcome
Concomitant
Medication
Administered
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Mild
Recovering/
Resolving
No
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Moderate
Unknown
Yes
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 163 of 192
Listing 16.2.7.3.3     Non-Treatment-Emergent Adverse Events – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date/ Time of  
Study Drug
Administration
System Organ Class/
Preferred Term/
Adverse Event
Onset Date/ Time/
Study Day
Resolution Date/ 
Time
Study Day
Severity
Outcome
Concomitant
Medication
Administered
xxxxx
DDMONYYYY/
HH:MM
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Mild
Recovering/
Resolving
No
XXXXXXXXXXX/
YYYYYYYYYYY/
ZZZZZZZZZZZZZ
DDMONYYYY/ HH:MM/
XX
DDMONYYYY/ HH:MM/
XX
Moderate
Unknown
Yes
Adverse Events coded using MedDRA Version X.X.
[1] TEAE = Treatment Emergent Adverse Event.


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Page 164 of 192
Listing 16.2.8.1.1.1
Hematology – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter
(unit)
Visit
Hematology Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Hemoglobin
(g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x 
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Listing 16.2.8.1.1.2
Hematology – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Hematology Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Hemoglobin
(g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Listing 16.2.8.1.1.3
Hematology – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Parameter
(unit)
Visit
Hematology Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Hemoglobin
(g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Listing 16.2.8.1.2.1
Chemistry – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter 
(unit)
Visit
Chemistry Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Albumin (g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Listing 16.2.8.1.2.2
Chemistry – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Chemistry Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Albumin (g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 169 of 192
Listing 16.2.8.1.2.3
Chemistry – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Parameter
(unit)
Visit
Chemistry Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
Albumin (g/L)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 170 of 192
Listing 16.2.8.1.3.1     Coagulation – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter
(unit)
Visit
Coagulation Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
INR (unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 171 of 192
Listing 16.2.8.1.3.2
Coagulation – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Coagulation Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
INR (unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 172 of 192
Listing 16.2.8.1.3.3
Coagulation – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Parameter
(unit)
Visit
Coagulation Sample
Collected/ If No, 
Reason
Sample Collection
Date/ Time
Actual
Value
Actual Change
from
Baseline[1]
Normal Range
(Low, High)
Flag[2]
xxxxx
INR (unit) 
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
H, CS
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
H, CS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
(xxx.x, xxx.x)
L, NCS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 173 of 192
Listing 16.2.8.1.4.1     Urinalysis – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter
(unit)
Visit
Urinalysis Sample 
Collected/ If No, Reason
Sample Collection
Date/ Time
Actual
Value
Normal Range
(Low, High)
Flag[2]
xxxxx
Glucose
Screening
Yes
DDMONYYYY/
HH:MM
Negative
Day -1[1]
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
H, NCS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, CS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, NCS
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Listing 16.2.8.1.4.2     Urinalysis – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Urinalysis Sample 
Collected/ If No, Reason
Sample Collection
Date/ Time
Actual
Value
Normal Range 
(Low, High)
Flag[2]
xxxxx
Glucose
Screening
Yes
DDMONYYYY/
HH:MM
Negative
Day -1[1]
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
H, NCS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, CS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Protocol: AB001
Page 175 of 192
Listing 16.2.8.1.4.3     Urinalysis – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Urinalysis Sample 
Collected/ If No, Reason
Sample Collection
Date/ Time
Actual
Value
Normal Range
(Low, High)
Flag[2]
xxxxx
Glucose
Screening
Yes
DDMONYYYY/
HH:MM
Negative
Day -1[1]
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Day XX
Yes
DDMONYYYY/
HH:MM
Positive
Parameter
(unit)
Screening
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
H, NCS
Day -1[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, CS
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
Day XX
Yes
DDMONYYYY/
HH:MM
xxx.x
(xxx.x, xxx.x)
L, NCS
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] H = Above High Range, L = Below Low Range, NCS = Not Clinically Significant, CS = Clinically Significant.


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Page 176 of 192
Listing 16.2.8.2.1.1     Vital Signs – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
Vital Signs 
Performed/ If 
No, Reason
Date/ Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation
xxxxx
Heart Rate
(beats/min)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
XX Hrs Post
Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
Normal
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] NCS = Not Clinically Significant, CS = Clinically Significant. 


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Page 177 of 192
Listing 16.2.8.2.1.2     Vital Signs – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
Vital Signs 
Performed/ If 
No, Reason
Date/ Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation
xxxxx
Heart Rate
(beats/min)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
XX Hrs Post
Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
Normal
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] NCS = Not Clinically Significant, CS = Clinically Significant. 


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Protocol: AB001
Page 178 of 192
Listing 16.2.8.2.1.3     Vital Signs – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
Vital Signs 
Performed/ If 
No, Reason
Date/ Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation[2]
xxxxx
Heart Rate
(beats/min)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/ 
HH:MM
xxx.x
N/A
Normal
XX Hrs Post
Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
Normal
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration. 
[2] NCS = Not Clinically Significant, CS = Clinically Significant.


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Protocol: AB001
Page 179 of 192
Listing 16.2.8.2.2.1
12-Lead Electrocardiogram – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
ECG Performed/
If No, Reason
Date/Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation
[2]
Details
xxxxx
PR Interval
(msec)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
xxxxxxxxx
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
XX Hrs Post Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
N/A
xxxxxxxxx
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
[2] NCS = Not Clinically Significant, CS = Clinically Significant.


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Protocol: AB001
Page 180 of 192
Listing 16.2.8.2.2.2     12-Lead Electrocardiogram – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
ECG Performed/
If No, Reason
Date/Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation
[2]
Details
xxxxx
PR Interval
(msec)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
xxxxxxxxx
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
XX Hrs Post Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
N/A
xxxxxxxxx
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
[2] NCS = Not Clinically Significant, CS = Clinically Significant.


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Protocol: AB001
Page 181 of 192
Listing 16.2.8.2.2.3     12-Lead Electrocardiogram – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Parameter
(unit)
Visit
Scheduled
Timepoint
ECG Performed/
If No, Reason
Date/Time of
Assessment
Actual
Value
Actual
Change from
Baseline[1]
Interpretation
[2]
Details
xxxxx
PR Interval
(msec)
Screening
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Abnormal NCS
xxxxxxxxx
Day -1
N/A
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
Day XX
Pre Dose[1]
Yes
DDMONYYYY/
HH:MM
xxx.x
N/A
Normal
XX Hrs Post Dose
Yes
DDMONYYYY/
HH:MM
xxx.x
xxx.x
N/A
xxxxxxxxx
etc.
[1] Baseline value. Baseline is defined as the last available, non-missing assessment on or prior to first study drug administration.
[2] NCS = Not Clinically Significant, CS = Clinically Significant.


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Protocol: AB001
Page 182 of 192
Listing 16.2.8.2.3.1     Physical Examination – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Physical
Examination
Type/ Visit
Physical
Examination
Performed/ If No, 
Reason (Reason
Applies to Full 
Examination)
Change from 
Previous
Examination
(Applies to Brief
Examination)
Date of
Assessment
Body System
Result[1]
Details
xxxxx
Full/ Screening
Yes
N/A
DDMONYYY
General
appearance
Normal
Skin
Abnormal NCS
xxxxxxxxxxxxxxxxxxx
xxx
Head, ears, eyes, 
nose,
throat
Normal
etc.
[1] NCS = Not Clinically Significant, CS = Clinically Significant. 


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 183 of 192
Listing 16.2.8.2.3.2     Physical Examination – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Physical
Examination
Type/ Visit
Physical
Examination
Performed/ If No, 
Reason (Reason 
Applies to Full 
Examination)
Change from 
Previous
Examination
(Applies to Brief
Examination)
Date of
Assessment
Body System
Result[1]
Details
xxxxx
Full/ Screening
Yes
N/A
DDMONYYY
General
appearance
Normal
Skin
Abnormal NCS
xxxxxxxxxxxxxxxxxxx
xxx
Head, ears, eyes, 
nose,
throat
Normal
etc.
etc.
[1] NCS = Not Clinically Significant, CS = Clinically Significant. 


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 184 of 192
Listing 16.2.8.2.3.3     Physical Examination – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Physical
Examination
Type/ Visit
Physical
Examination
Performed/ If No, 
Reason (Reason 
Applies to Full 
Examination)
Change from 
Previous
Examination
(Applies to Brief
Examination)
Date of
Assessment
Body System
Result[1]
Details
xxxxx
Full/ Screening
Yes
N/A
DDMONYYY
General
appearance
Normal
Skin
Abnormal NCS
xxxxxxxxxxxxxxxxxxx
xxx
Head, ears, eyes, 
nose,
throat
Normal
etc.
etc.
[1] NCS = Not Clinically Significant, CS = Clinically Significant. 


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 185 of 192
Listing 16.2.8.2.4.1     Chest X-Ray – Low Dose (Intent-to-Treat Population)
Treatment Group: LSALT 0.01 mg
Subject
Number
Visit
Chest X-Ray Performed/ If No, 
Reason
Test Date
Result[1]
Details
xxxxx
Screening
Yes
DDMONYYYY
Normal
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
[1] NCS = Not Clinically Significant, CS = Clinically Significant.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 186 of 192
Listing 16.2.8.2.4.2     Chest X-Ray – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Visit
Chest X-Ray Performed/ If No, 
Reason
Test Date
Result[1]
Details
xxxxx
Screening
Yes
DDMONYYYY
Normal
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
etc.
[1] NCS = Not Clinically Significant, CS = Clinically Significant.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 187 of 192
Listing 16.2.8.2.4.3     Chest X-Ray – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject 
Number
Visit
Chest X-Ray Performed/ If No, 
Reason
Test Date
Result[1]
Details
xxxxx
Screening
Yes
DDMONYYYY
Normal
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
etc.
[1] NCS = Not Clinically Significant, CS = Clinically Significant.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 188 of 192
Listing 16.2.8.2.5.2     Plasma Pharmacokinetic Concentrations – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
Date/ Time of
Study Drug
Administration
Visit
Scheduled
Timepoint
Blood Sample 
Collected/ If No, 
Reason
Date/ Time
of Collection
Duration From Study 
Drug Admistration
(hours)
Concentration
(unit)
xxxxx
DDMONYYYY/ HH:MM
Day 1
30 mins pre start of 
Infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
15 mins after end of 
1st infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
30 mins after end of 
1st infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
etc.
etc.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 189 of 192
Listing 16.2.8.2.5.3
Plasma Pharmacokinetic Concentrations – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Date/ Time of First
Study Drug
Administration
Visit
Scheduled
Timepoint
Blood Sample
Collected/
If No, 
Reason
Date/ Time
of Collection
Duration From 
First Study Drug 
Admistration
(hours)
Duration From Study 
Drug Admistration of
Dosing Day 
(hours)
Concentration
(unit)
xxxxx
DDMONYYYY/ HH:MM
Day 1
30 mins pre start 
of Infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
xx.xx
15 mins after end 
of 1st infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
xx.xx
30 mins after end 
of 1st infusion
Yes
DDMONYYY/ HH:MM
xx.xx
xx.xx
xx.xx
etc.
etc.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 190 of 192
Listing 16.2.8.2.6.2
Plasma Pharmacokinetic Parameters – SAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 1/Placebo
Subject
Number
AUC0-t 
(unit)
Cmax
(unit)
etc.
xxxxx
xxx.x
xxx.x
xxx.x
xxxxx
xxx.x
xxx.x
xxx.x
xxxxx
xxx.x
xxx.x
xxx.x
xxxxx
xxx.x
xxx.x
xxx.x
xxxxx
xxx.x
xxx.x
xxx.x
xxxxx
xxx.x
xxx.x
xxx.x
etc.
Programming Note: Include all plasma PK parameters.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 191 of 192
Listing 16.2.8.2.6.3
Plasma Pharmacokinetic Parameters – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Plasma PK Parameter Day
AUC0-t 
(unit)
Cmax
(unit)
etc.
xxxxx
Day 1
xxx.x
xxx.x
xxx.x
xxxxx
Day 3
xxx.x
xxx.x
xxx.x
xxxxx
Day 1
xxx.x
xxx.x
xxx.x
xxxxx
Day 3
xxx.x
xxx.x
xxx.x
xxxxx
Day 1
xxx.x
xxx.x
xxx.x
xxxxx
Day 3
xxx.x
xxx.x
xxx.x
etc.
etc.
Programming Note: Include all plasma PK parameters.


Arch Biopartners Inc.
Confidential
Protocol: AB001
Page 192 of 192
Listing 16.2.8.2.7.3     Anti-Drug Antibody – MAD (Intent-to-Treat Population)
Cohort/Treatment Group: Cohort 4/Placebo
Subject
Number
Visit
Sample Collected/ If No, Reason
Collection Date/ Time
xxxxx
Day 14
Yes
DDMONYYYY/
HH:MM
etc.