Clinical trial NCT05619536
Conditions: Healthy
Sponsor: Cidara Therapeutics Inc.
Start date: 2022-10-18; Completion date: 2023-07-14
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when dosed by subcutaneous (SQ) administration as a single dose to healthy Japanese adult subjects.

Detailed description:
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals are to assess safety, tolerability, and pharmacokinetics (PK) of CD388.

Arms: arm 1: 9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection arm 2: 9 subjects randomized in a 7:2 ratio to receive either 150 mg CD388 SQ injection or matching placebo injection arm 3: 9 subjects randomized in a 7:2 ratio to receive either 450 mg CD388 SQ injection or matching placebo injection
Interventions: intervention 1: CD388 Injection intervention 2: Saline placebo
Intervention descriptions: intervention 1: CD388 liquid for injection intervention 2: Sterile normal saline for injection

Protocol documents:
Prot_000.pdf: 
Study Protocol 
 
 
Title: 
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to 
Determine the Safety, Tolerability, and Pharmacokinetics of CD388 
Subcutaneous Administration in Healthy Japanese Subjects 
NCT Number: 
NCT05619536 
Document Date: 
12 DEC 2022 
 


Cidara Therapeutics, Inc. 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential 
Page 1 of 74 
PROTOCOL TITLE PAGE 
Title 
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to 
Determine the Safety, Tolerability, and Pharmacokinetics of CD388 
Subcutaneous Administration in Healthy Japanese Subjects 
Study Drug 
CD388 Injection 
Original Protocol 
09AUG2022 
Amendment 1 
12DEC2022 
Sponsor 
Cidara Therapeutics, Inc. 
6310 Nancy Ridge Dr., Suite 101 
San Diego, California 92121, USA 
Telephone: +1.858.752.6170 
Facsimile: +1.858.408.3509 
Sponsor Medical Monitor 
Ozlem Equils, MD, FAAP 
Cidara Therapeutics, Inc. 
6310 Nancy Ridge Dr., Suite 101 
San Diego, California 92121, USA 
Mobile: 
+1.310.595.4094 
Email: 
oequils@cidara.com 
Sponsor Clinical Project Manager 
Joaquin Sosa 
Cidara Therapeutics, Inc. 
6310 Nancy Ridge Drive, Suite 101 
San Diego, California 92121, USA 
Office: 
+1.858.249.7394
Email: 
jsosa@cidara.com
Regulatory Agency Identifier 
Number(s): 
IND 155,536 
Confidentiality Statement: 
This document is a confidential communication from Cidara Therapeutics, Inc. Acceptance of this 
document constitutes an agreement by the recipient(s) that no information contained herein will 
be published or disclosed without prior written approval from Cidara Therapeutics, Inc., except 
that this document may be disclosed to appropriate Institutional Review Boards and/or Ethics 
Committees under the condition that they are also required to maintain confidentiality. 


Cidara Therapeutics, Inc.
Protocol CD388.SQ.1.03
CD388 Injection
Amendment 1
Confidential 
Page 2 of 74
PROTOCOL APPROVAL PAGE
Protocol: CD388.SQ.1.03
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the 
Safety, Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration 
in Healthy Japanese Subjects
Original Protocol:
09AUG2022
Amendment 1:
12DEC2022
SPONSOR SIGNATURE
Signature
Taylor Sandison, MD, MPH
Chief Medical Officer
Cidara Therapeutics, Inc.
Date



Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 3 of 74 
1. 
PROTOCOL SYNOPSIS 
Sponsor: Cidara Therapeutics Inc., San Diego, CA 
Product Name: CD388 Injection  
Active Ingredients: CD388 
Protocol Title: A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, 
Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese Subjects 
Planned Study Centers: Single center in the United States 
Phase of Development: 1 
Indication: Influenza virus infection 
IND Number: 155,536 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
 
x To determine the safety and tolerability 
profile of CD388 Injection when dosed by 
subcutaneous (SQ) administration as a single 
dose to healthy Japanese adult subjects. 
x Incidence and severity of treatment-emergent 
adverse events (TEAEs), including but not limited 
to adverse events (AEs) and serious adverse events 
(SAEs) (including systemic reactogenicity/
injection site reactions and hypersensitivity 
reactions), AEs leading to study drug 
discontinuation and/or study withdrawal, vital 
signs, 12-lead electrocardiograms (ECGs), 
and clinical laboratory tests (including hematology, 
coagulation, serum chemistry, and urinalysis), after 
a single dose of CD388. 
Secondary 
 
x To determine the plasma pharmacokinetic 
(PK) profile of CD388 Injection when dosed 
by SQ administration as a single dose to 
healthy Japanese adult subjects. 
x Pharmacokinetic parameters following CD388 
Injection administration: maximum plasma 
concentration (Cmax), time to maximum plasma 
concentration (Tmax), terminal elimination half-life 
(t½), apparent clearance (CL/F), apparent volume 
of distribution (VZ/F), area under the plasma 
concentration-time curve from time 0 to time of 
last quantifiable sample (AUC0-last), area under the 
plasma concentration-time curve from time 0 
extrapolated to infinity (AUC0-). 
Exploratory 
x To evaluate the PK profile of CD388 in upper 
respiratory tract after SQ administration as 
a single dose to healthy Japanese adult 
subjects. 
x Pharmacokinetic parameters following CD388 
Injection administration: maximum 
nasopharyngeal (NP) concentration (Cmax), time to 
maximum NP concentration (Tmax), area under the 
NP concentration-time curve from time 0 to time 
of last quantifiable sample (AUC0-last). 
 
 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 4 of 74 
 
 
Objectives 
Endpoints 
Exploratory (continued) 
 
x To evaluate biomarkers that may be 
associated with safety, reactogenicity, 
and immunogenicity after CD388 Injection. 
x Results of the analyses of exploratory biomarkers 
(including but not limited to cytokines, 
chemokines, acute phase reactants, etc.). 
x To evaluate CD388 immunogenicity. 
x Anti-drug antibody (ADA) titers in blood (plasma 
or serum). 
x To explore the effect of CD388 Injection on 
the occurrence of influenza-like illness 
(during flu season). 
x Occurrence of influenza-like illness reporting 
during the outpatient follow-up period. 
  
Study Design  
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD388 
Injection administered SQ to healthy Japanese adult subjects. The goals are to assess safety, tolerability, and PK 
of CD388.  
Subjects will be randomized to receive a single dose of CD388 or placebo administered via SQ injection 
(treatment assignment is blinded) according to the design in the table below.  
Number of Subjects (N = 27) 
Cohort: dose 
CD388 
(n = 21) 
Placebo 
(n = 6) 
Cohort 1: 50 mg 
7 
2 
Cohort 2: 150 mg 
7 
2 
Cohort 3: 450 mg 
7 
2 
Note: A subject may not receive treatment in more than one cohort. 
After 50% of Cohort 1 subjects have completed study drug administration and have undergone protocol-specified 
procedures and DVVHVVPHQWVIRU10 days, the Principal Investigator (PI) and Sponsor will review blinded safety 
data: AEs (including systemic reactogenicity/injection site reactions, hypersensitivity reactions, and adverse 
events of special interest [AESIs]), vital signs, 12-lead ECGs, and clinical laboratory results (hematology, 
coagulation, serum chemistry, urinalysis) to determine the safety and tolerability of the study drug. The incidence 
and severity of AEs, and any adverse changes in vital signs, clinical laboratory findings, and ECGs will be 
considered when determining safety and tolerability of study drug. If the dose is determined to be safe and well 
WROHUDWHG10 days after dosing, Cohort 2 will be enrolled. Enrollment of the remaining 50% of Cohort 1 will 
continue while the safety data of the first 50% of Cohort 1 is being reviewed. Similar processes will be followed 
for dose escalation from Cohort 2 to Cohort 3. 
The Schedule of Events is presented in Table 1. All subjects will be admitted to the clinical research unit (CRU) 
for observation and safety assessments from Day -1 (check-in) to Day 14. Subjects will be monitored for AEs 
(including systemic reactogenicity/injection site reactions, hypersensitivity reactions and AESIs) and SAEs 
throughout the study until the final study visit after dosing. Safety will also be assessed by physical examinations, 
ECGs, vital signs measurements, and laboratory evaluations (hematology, coagulation, serum chemistry, 
urinalysis) at various time points during and after the CRU stay. Concomitant medication use will be recorded 
throughout the study.  
Blood samples for PK and ADA assessments will be collected throughout the study. To maintain the blind, 
samples will be collected from all subjects; however, only samples from the CD388 Injection group will be 
analyzed (using validated assays) by an unblinded central bioanalytical laboratory. Additional blood samples will 
be collected for pharmacogenomics and exploratory biomarker evaluation. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 5 of 74 
Respiratory tract infection (RTI) surveillance will be conducted during the outpatient phase of the study from 
CRU discharge through the Day 120/165 outpatient visit or a lab-confirmed influenza infection, whichever occurs 
first. Subjects will be provided nasal/throat swab kits (for detection of influenza infection or other respiratory 
pathogen by a multiplexed polymerase chain reaction [PCR] test) and symptom diary cards.  
If 3 or more RTI symptoms listed in the table below occur (at least one must be a respiratory symptom), subjects 
will contact study staff, then collect nasal/throat swab samples (the swabs should take place as soon as possible 
after the start of symptoms, ideally within 48 hours, but no later than 5 days). Subjects will complete symptom 
diary cards every 7 days to capture the worst grade of symptoms that occurred during the previous week. The 
Investigator/study staff will arrange for prompt shipment of the nasal/throat samples to the testing laboratory. 
Note: If the reported symptoms are already of a level of severity that urgent care is indicated, the subject should 
be directed to the appropriate facility to receive this care (e.g., emergency room). Otherwise, symptoms should be 
treated according to standard of care. 
If an influenza infection is confirmed by the testing laboratory before the Day 120/165 outpatient visit, the event 
should be documented until all symptoms have resolved, including completion of the symptom diary card every 
7 days. Thereafter, no further RTI surveillance will be carried out on the subject.  
If the nasal/throat swab samples are not confirmed to be influenza by the testing laboratory, diary card 
completion will continue through the Day 120/165 outpatient visit.  
Respiratory Tract Infection (RTI) Symptoms 
x Runny nose (rhinorrhea) 
x Shortness of breath (dyspnea) 
x Stuffy nose (nasal congestion) 
x Wheeze 
x Sore throat 
x Chilliness/feverishness or temperature °F 
x Earache 
x Headache 
x Cough 
x Body ache 
x Productive phlegm/sputum 
 
As part of the surveillance, subjects will be questioned during all outpatient site visits for RTI symptoms. If the 
interval to the next outpatient site visit exceeds 15 days, subjects will be contacted by the Investigator/study staff 
every 2 weeks to query for RTI symptoms. Subjects should be reminded to contact the Investigator/study staff if 
RTI symptoms occur, and to collect the nasal/throat swab samples and complete the symptom diary cards every 
7 days. 
Number of Subjects  
A total of 27 subjects will be enrolled in this study; 21 to receive CD388 Injection and 6 to receive placebo. 
Inclusion Criteria  
Subjects must meet ALL the following inclusion criteria: 
1. Must be of Japanese descent with Japanese parents and grandparents, as determined by subject's verbal 
report. 
2. Willing and able to provide written informed consent. 
3. Males and females 18 to 65 years of age, inclusive. 
4. A female subject must meet one of the following criteria: 
a. 
If of childbearing potential – agrees to use a highly effective, preferably user-independent method 
of contraception (failure rate of <1% per year when used consistently and correctly) for at least 
30 days prior to screening and agrees to remain on a highly effective method until 7 months after 
last dose of study medication. Examples of highly-effective methods of contraception are located in 
Appendix 1. 
b. If a female of non-childbearing potential – should be surgically sterile (i.e., has undergone complete 
hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion without reversal surgery) or in 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 6 of 74 
a menopausal state (at least 1 year without menses), as confirmed by follicle-stimulating hormone 
)6+OHYHOVP,8P/ 
5. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test 
ȕ-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the 
first dose of study drug. 
6. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during 
the study and for a period of at least 7 months after study drug administration. 
7. A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double 
barrier method (e.g., condom and spermicide) and agree not to donate sperm during the study and for at 
least 7 months after the last dose of the study medication. 
8. Good health and without signs or symptoms of current illness. 
9. Normal clinical examination, including: 
a. 
No physical examination findings that an Investigator determines would interfere with interpretation 
of study results. 
b. Screening ECG without clinically significant abnormalities (see Appendix 2).  
c. 
&UHDWLQLQHFOHDUDQFH&U&/P/PLQDVFDOFXODWHGXVLQJthe Cockcroft-Gault equation: 
ܥݎܥܮ= 
(140 െܽ݃݁) × (ݓ݄݁݅݃ݐ ݅݊ ݇݃)
72 × (ݏ݁ݎݑ݉ ܿݎ݁ܽݐ݅݊݅݊݁ ݅݊ ݉݃/݀ܮ) × (0.85 ݂݅ ݂݈݁݉ܽ݁) 
d. Negative urine screen for drugs of abuse and alcohol at screening and Day -1. 
10. Body weight 50 kg and body mass index between 18.0 and 30.0 kg/m2, inclusive, using the following 
equation: 
ܤܯܫ=
(ݓ݄݁݅݃ݐ ݅݊ ݇݃)
(݄݄݁݅݃ݐ ݅݊ ݉݁ݐ݁ݎݏ)ଶ 
11. Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including 
contact sports, at any time from screening through 30 days after any dose of study drug. 
12. Subject has adequate venous access for blood collection. 
Exclusion Criteria 
Subjects must NOT meet any of the following exclusion criteria: 
1. History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors 
(i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; 
or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema 
multiforme, or toxic epidermal necrolysis [TEN]). 
2. History of any of the following: 
a. 
Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene 
glycol [PEG], etc.). 
b. Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases. 
c. 
Atopic dermatitis or psoriasis. 
d. Bleeding disorder. 
e. 
Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental 
conditions. 
f. 
Migraines. 
g. Syncope, or vasovagal syndrome with injections or blood draws. 
h. Cardiac arrythmia considered clinically significant by the Investigator. 
3. Subjects with one or more of the following laboratory abnormalities at screening as defined by the 
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017): 
a. 
6HUXPFUHDWLQLQH*UDGHîXSSHUOLPLWRIQRUPDO>8/1@. 
b. Pancreatic amylDVHRUOLSDVH*UDGHî8/1. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 7 of 74 
c. 
$VSDUWDWHDPLQRWUDQVIHUDVH$67RUDODQLQHDPLQRWUDQVIHUDVH$/7*UDGHî8/1. 
d. 7RWDOELOLUXELQ*UDGHî8/1. 
e. 
$Q\RWKHUWR[LFLW\*UDGHH[FHSWIRU*UDGHHOHYDWLRQVRIWULJO\FHULGHVORZGHQVLty lipoprotein 
cholesterol, and/or total cholesterol. 
f. 
Any other laboratory abnormality considered to be clinically significant by the Investigator. 
Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed once without 
prior asking approval from the Sponsor. Retesting will take place during a scheduled or unscheduled 
visit during screening. Subjects with a normal value at retest may be included. 
4. Alcohol or drug addiction in the past 2 years. 
5. Experiencing symptoms of acute illness or chronic disease within 14 days prior to clinical research unit 
(CRU) check-in.  
6. At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus antibody, or human 
immunodeficiency virus (HIV) antibody.  
7. A positive result at CRU check-in for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 
by polymerase chain reaction (PCR). 
8. Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 
(COVID-19). Full COVID-19 vaccination prior to participation is strongly recommended. 
9. Women who are pregnant or nursing. 
10. Received any over-the-counter (OTC) medications or nutritional supplements within 7 days, or any 
prescription medications within 14 days or <5 half-lives prior to dosing, whichever is longest (except for 
hormonal contraceptives, acetaminophen, or ibuprofen). 
11. Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening. 
12. Received any vaccines or immunoglobulins within 28 days prior to dosing (90 days in case of 
intravenous immunoglobulin [IVIg] or biologics, or 14 days for COVID-19 vaccine). 
13. Donated blood (within 56 days of screening) or plasma (within 7 days of screening) or experienced 
significant blood loss or significant blood draw (blood donation or blood loss of 500 mL) when 
participating in non-interventional clinical trials within 30 days prior to dosing. 
14. Received a blood transfusion within 28 days prior to dosing. 
15. Received any biologics within 90 days prior to dosing; or previous participation in another study 
(including investigational device studies) within 30 days of dosing or 5 half-lives of the study drug, 
whichever is longer, prior to screening (prior participation at any time in non-invasive methodology 
trials in which no drugs were given is acceptable). 
16. Previous treatment with CD388. 
17. Preplanned surgery at any time during the study. 
18. The Principal Investigator (PI) considers that the volunteer should not participate in the study. 
Test Product, Dose and Mode of Administration  
CD388 Injection is a clear to lightly opalescent liquid essentially free of particulate matter containing the active 
pharmaceutical ingredient, CD388. CD388 Injection is supplied as a frozen sterile solution in single-use vials. 
CD388 Injection is administered by subcutaneous (SQ) injection at 50 mg, 150 mg, or 450 mg (Cohort 1,  Cohort 
2, or Cohort 3, respectively). Dose levels to be assessed will follow an ascending single-dose regimen with the 
starting dose based on findings from 3-month rat and monkey toxicology studies. 
Comparator 
Normal saline will be administered SQ as the placebo control. 
Duration of Treatment 
A single dose of study drug will be administered SQ on Day 1. Study participation will require up to 28 days for 
screening procedures, and ~120/165 days for dosing and follow-up (check-in to the CRU on Day -1; CRU 
inpatient stay for study drug administration, observation, and assessments and procedures for 15 days [Days -1 
to Day 14]; and 5 CRU outpatient visits for additional assessments and procedures). 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 8 of 74 
Criteria for Evaluation 
Safety and Tolerability of Study Drug 
Safety and tolerability will be assessed by monitoring AEs (including systemic reactogenicity/injection site 
reactions, hypersensitivity reactions, and AESIs), vital signs, 12-lead ECGs, clinical laboratory results 
(hematology, coagulation, serum chemistry, urinalysis), and concomitant medication usage throughout the study.  
See the Study Design section for details regarding cohort/dose level enrollment timing and assessment of safety 
and tolerability for dose escalation decision. 
If a dose level is considered not safe or well tolerated, the study drug assignment for the subject(s) with the safety 
issue may be unblinded. The Sponsor may also independently decide to unblind the entire cohort for safety 
concerns or terminate enrollment for any reason. 
,IDQ\VXEMHFWGHYHORSVD*UDGH$(or an SAE of any grade that is deemed related to the study drug, the 
mechanism of the AE may be assessed (i.e., cytokine level, complement activation, immunoglobulin G [IgG] 
subtypes, immunoglobulin E [IgE], T-cell/B-cell/monocyte and basophil activation as assessed by flow 
cytometry, ADA development, and immune complex formation) at Sponsor and Investigator discretion, and the 
study dose may be modified for the remainder of the study. 
Pharmacokinetics/Anti-drug Antibodies 
Pharmacokinetics will be determined by analyzing plasma samples for concentration of CD388 obtained from 
subjects who receive CD388 Injection in each cohort at various time points after administration of study drug. 
Anti-drug antibodies (ADA) will also be measured at selected time points by a validated enzyme-linked 
immunosorbent assay (ELISA) method. 
Pharmacogenomics 
A mandatory pharmacogenomic (DNA) blood sample will be collected once, preferably on Day 1 (collection at 
another time point is permitted if necessary) to allow for genetic research to help understand the characteristics 
of CD388. Genetic analysis will be conducted if it is hypothesized that this may help explore genetic markers that 
could explain differences in safety, immunogenicity, or clinical response among subjects. Host DNA assessment 
will be limited to research related to CD388, including the development of tests/assays related to CD388 
and flu-like disease. 
Analyses of host DNA may be conducted at the Sponsor’s discretion and reported separately from the study 
report. 
Exploratory Biomarkers 
Blood samples will be collected to allow for the exploration of biomarkers on the assumption that these markers 
could play a role in the response (safety, reactogenicity, immunogenicity) to CD388. 
These samples and remaining material from other samples may be used for further assay optimization/
qualification, biomarkers, or further exploratory analyses. Samples will only be used for research related to 
influenza virus infection, flu-like disease, and safety, reactogenicity, and immunogenicity of CD388, including 
the development of tests/assays related to CD388 and influenza. 
Analyses of biomarkers may be conducted at the Sponsor’s discretion and reported separately from the study 
report. 
Withdrawal from Study  
Subjects may be withdrawn from the study for any of the following reasons: 
x 
Subject is unable or unwilling to continue 
x 
Subject elects to withdraw informed consent 
x 
Adverse event (whether or not related to study drug) that precludes further participation in the study in 
the judgment of an Investigator and/or Sponsor 
x 
Protocol non-compliance 
x 
Subject lost to follow-up, or follow-up is not possible 
x 
The Investigator considers that it is in the subject’s best interest not to continue participation in the study 
If a subject is removed from the study for any reason, the subject will be followed for resolution of any ongoing 
AE(s). 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 9 of 74 
Temporary Study Halt for Safety Review 
The study will be temporarily halted, pending review of available data, if any of the following occur:  
x 
,IVXEMHFWVH[SHULHQFHWKHVDPH*UDGH$(HYHQWRUODERUDWRU\DEQRUPDOLW\ZLWKLQGD\VDIWHU
study drug administration, considered attributable to CD388 or cannot be attributed to another cause 
x 
,IVXEMHFWH[SHULHQFHVD*UDGH$(RUODERUDWRU\DEQRUPDOLW\ZLWKLQGD\VDIWHUVWXG\GUXJ
administration, considered attributable to CD388 or cannot be attributed to another cause 
x 
,IVXEMHFWH[SHULHQFHVDQ SAE irrespective of toxicity grade within 28 days after study drug 
administration, considered attributable to CD388 or cannot be attributed to another cause 
If it is considered appropriate to restart the study following an internal safety review, an amendment, if required, 
will be submitted to the Food and Drug Administration (FDA) and Institutional Review Board (IRB). The study 
will not restart until the amendment has been approved by the FDA and IRB. 
Statistical Methods  
Safety, tolerability, and PK will be summarized using descriptive statistics. There will be no formal hypothesis 
testing. Analysis populations are: 
x 
Safety Population: all subjects who receive any amount of study drug 
x 
PK Analysis Population: all subjects who receive CD388 Injection and who have any blood samples 
analyzed 
A Statistical Analysis Plan (SAP) will be prepared and finalized before unblinding for the first interim analysis. 
Any deviations from the final SAP will be described and justified in the study report. All statistical analyses will 
be performed using SAS®. 
Descriptive statistics, including the numbers and percentages for categorical variables, and the numbers, means, 
standard deviations, medians, minimums, and maximums for continuous variables, will be provided. All data will 
be summarized separately by dose level and study drug (CD388 Injection or placebo). Listings of individual 
subject data will also be produced.  
Safety will be evaluated by presenting summaries of AEs and SAEs, ECGs, clinical laboratory evaluations 
(hematology, coagulation, serum chemistry, urinalysis), and vital signs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA). The incidence of TEAEs and AESIs will be presented 
by System Organ Class (SOC) and Preferred Term (PT), relationship to study drug, and severity. A TEAE is 
defined as an AE that emerges during or after study drug administration having been absent pre-treatment, or 
worsens relative to the pre-treatment state, and through the final study visit. In addition, the incidence of serious 
TEAEs and TEAEs leading to discontinuation of study drug or from the study will be presented by SOC and PT. 
Descriptive statistics for clinical laboratory test results, ECG parameters, and vital signs, and for changes from 
Baseline, will be presented by time point. The incidences of potentially clinically significant (PCS) clinical 
laboratory results, ECG parameters, and vital signs will also be summarized by time point.  
A summary of the injection site evaluation will be presented. The number and percentage of subjects with any 
local reaction will be provided, as will the number and percentage of subjects with pain, tenderness, 
erythema/redness, and induration/swelling. The severity of each local reaction will also be presented. 
The number and percentage of subjects with any RTI will be provided. 
The PK parameters that will be assessed in the PK Analysis Population include: 
x maximum plasma concentration (Cmax) 
x time to maximum plasma concentration (Tmax) 
x terminal elimination half-life (t½) 
x apparent clearance (CL/F) 
x apparent volume of distribution (VZ/F)  
x area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-last) 
x area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-)  
Analysis of the ADA results is to be determined and may include determination of the subject’s positive/negative 
ADA status at baseline, treatment-emergent ADA in subjects with a negative baseline, as well as a post-baseline 
increase in titer for subjects with positive ADA at baseline. 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
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Page 10 of 74 
1.1. 
Schedule of Events 
Table 1: 
Schedule of Events 
 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits  
Day 
(Window) 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
30 
(±3) 
45 
(±3) 
60 
(±5) 
90 
(±7) 
120/165 a 
(±14) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion criteria  
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history/demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete physical with vital signs 
(BP, RR, HR, oral temperature, height, 
weight, BMI)  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted physical with vital signs 
(BP, RR, HR, oral temperature, weight b) 
 
X 
X c 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
Safety ECG d 
X 
X 
X 
 
 
X 
 
 
X 
X 
 
 
 
X 
Laboratory evaluations (CBC with 
platelets, coagulation, serum chemistry, 
lipids, urinalysis) 
X 
X 
 
X 
X e 
X 
 
 
X 
X 
X 
X 
X 
X 
Virology screening (HBV, HCV, HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (SARS-CoV-2) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Serum/urine pregnancy test f 
X 
X 
 
 
 
 
 
 
 
X 
 
X 
X 
X 
FSH (if applicable to confirm 
postmenopausal status) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drug/alcohol screen g 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Dosing of study drug 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Reactogenicity/injection site inspection h 
 
 
X  
X  
X 
 
 
 
 
 
 
 
 
 
PK sample collection i 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pharmacogenomics blood sample j 
 
 
predose 
 
 
 
 
 
 
 
 
 
 
 
Exploratory biomarker samples 
 
 
predose 
 
X e 
 
 
 
 
 
 
 
 
 
Anti-drug antibodies 
 
 
predose 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
Nasopharyngeal swab collection k 
 
 
predose 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Assess and record AEs l 
 
Concomitant medications/procedures 
review m 
 


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Abbreviations: AEs = adverse events; BMI = body mass index; BP = blood pressure, CBC = complete blood count; COVID-19 = coronavirus disease 2019; CRU = clinical 
research unit; DAR = drug-antibody ratio; ECG = electrocardiogram; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; HR = heart rate; hr = hour; ICF = informed consent form; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe acute respiratory 
syndrome coronavirus 2. 
Schedule of Events (continued) 
a. The timing of this visit is Day 120 for Cohort 1 and Day 165 for Cohorts 2 and 3. For subjects who discontinue study early, the Day 120/165 procedures 
should be performed. 
b. Weight should be measured at each of the outpatient visits (Days 30, 45, 60, 90, 120/165). 
c. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated, and will be measured with the subject in a seated position for at least 3 minutes prior to measurement.  
d. A triplicate 12-lead ECG is to be performed at screening, at CRU check-in on Day -1, predose (immediately prior to study drug administration) and 6 hours 
postdose (±10 minutes) on Day 1, and as indicated in the schedule. Subjects are to be resting (at least 5 minutes) and semi-recumbent when ECG is being 
conducted. 
e. Laboratory evaluations (including exploratory biomarker samples) need to be performed once during the Day 3–6 interval on Day 4. 
f. $VHQVLWLYHVHUXPSUHJQDQF\WHVWȕဩKXPDQFKRULRQLFJRnadotropin) is required at screening and Day 120/165 for females of childbearing potential. Urine 
pregnancy test may be performed at all other time points. 
g. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see Appendix 2). 
h. At indicated visits, inspection of administration site and surrounding area will be performed twice daily (once between approximately 2–4 hours postdose, 
and once approximately 8–12 hours postdose, then twice daily on other indicated study days at least 6 hours apart), with any abnormal findings reported as 
AEs. Reactions will be rated according to the scale provided in Table 5. 
i. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 2, 4, and 12 hours (each ±10 minute window); 24 hours (±30 minute 
window); 48 hours (±1 hour window); 72, 96, 120 hours (each ±2 hour window); and in the morning on Days 7, 9, 11, 14. Postdose samples collected at 
outpatient CRU visits at Days 30, 45, 60, 90, and 120/165 have the same windows (i.e., in ±days) as the visits.  
j. A mandatory pharmacogenomic (DNA) blood sample will be collected once, preferably on Day 1 (collection at another time point is allowed if necessary) to 
allow for pharmacogenomic research related to CD388. 
k. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, and 30. 
l. Adverse events (including influenza-like illness which will be tested for both COVID-19 and flu) will be collected for all subjects from the time of signing 
the ICF through the final study visit. 
m. Concomitant medication and procedures, including those used to treat an AE, will be recorded from 28 days prior to the CD388 Injection/placebo 
administration until the final study visit.  
 


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1.2.
Study Schema
Cohort 1a
50 mg single dose
ose
Postdose follow-up thru Day 120 
(CRU inpatient stay thru Day 14)
Cohort 2
150 mg single dose
d
f ll
h
Postdose follow-up thru Day 165 
(CRU inpatient stay thru Day 14)
dose
Cohort 1a
15
SQ
N = 27 total –  N = 9 per Cohort (7 CD388 Injection : 2 Placebo)
Cohort 3
450 mg single dose
Postdose follow up thru Day 165
ose
Postdose follow-up thru Day 165 
(CRU inpatient stay thru Day 14)
Cohort 2
i
l d
45
Dose the 9 subjects in Cohort 1. After 50% of the subjects have completed protocol-specified procedures and assessments for шϭϬ days and the dose is determined 
to be safe and well tolerated, Cohort 2 will be enrolled and randomized. Enrollment of the remaining 50% of Cohort 1 will continue while the safety data of the first 
50% of Cohort 1 is being reviewed. Similar processes will be followed for dose escalation from Cohort 2 to Cohort 3. 
a


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2. 
TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS .............................................................................................3 
1.1. 
Schedule of Events .....................................................................................................10 
1.2. 
Study Schema .............................................................................................................12 
2. 
TABLE OF CONTENTS ...........................................................................................13 
2.1. 
LIST OF TABLES ......................................................................................................17 
3. 
LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF 
TERMS .......................................................................................................................18 
4. 
BACKGROUND AND RATIONALE .......................................................................21 
4.1. 
Background .................................................................................................................21 
4.1.1. 
Influenza – Prevention and Treatment ........................................................................21 
4.1.2. 
CD388 – A Long-Acting Antiviral Fc-Conjugate ......................................................22 
4.1.2.1. 
CD388 Nonclinical Studies ........................................................................................22 
4.1.2.2. 
CD388 Clinical Studies ..............................................................................................23 
4.2. 
Summary of Benefits and Risks .................................................................................23 
4.3. 
Justification of Dose ...................................................................................................24 
4.4. 
Population to be Studied .............................................................................................25 
4.5. 
Rationale for Trial Endpoints .....................................................................................25 
4.6. 
Statement of Compliance ............................................................................................25 
5. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................26 
6. 
STUDY DESIGN .......................................................................................................27 
6.1. 
Description of the Study .............................................................................................27 
6.2. 
Criteria for Evaluation ................................................................................................28 
6.2.1. 
Safety and Tolerability of Study Drug ........................................................................28 
6.2.2. 
Pharmacokinetics/Anti-drug Antibodies ....................................................................29 
6.2.3. 
Pharmacogenomics .....................................................................................................29 
6.2.4. 
Exploratory Biomarkers ..............................................................................................29 
6.3. 
Number of Subjects ....................................................................................................29 
6.4. 
Measures Taken to Minimize Bias .............................................................................30 
6.5. 
Expected Duration of Subject Participation ...............................................................30 
6.6. 
Method of Treatment Assignment and Blinding ........................................................30 
6.7. 
Data Review Committee .............................................................................................30 


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7. 
SELECTION, DISCONTINUATION, AND WITHDRAWAL OF 
SUBJECTS .................................................................................................................32 
7.1. 
Subject Inclusion Criteria ...........................................................................................32 
7.2. 
Subject Exclusion Criteria ..........................................................................................33 
7.3. 
Requalification for Entry ............................................................................................35 
7.4. 
Subject Withdrawal Criteria .......................................................................................35 
7.4.1. 
Withdrawal from Study Protocol ................................................................................35 
7.5. 
Replacement of Subjects .............................................................................................35 
7.6. 
Temporary Study Halt for Safety Review ..................................................................35 
7.7. 
Study Termination by Sponsor and Termination Criteria ..........................................36 
8. 
STUDY DRUG ...........................................................................................................37 
8.1. 
CD388 Injection ..........................................................................................................37 
8.1.1. 
Directions for Use .......................................................................................................37 
8.1.2. 
Drug Storage ...............................................................................................................37 
8.1.3. 
Dose Adjustment ........................................................................................................37 
8.2. 
Placebo Injection ........................................................................................................37 
8.3. 
Compliance .................................................................................................................37 
8.4. 
Breaking the Blind ......................................................................................................37 
8.5. 
Previous and Concomitant Medications and Substances ............................................38 
8.6. 
Accountability Procedures ..........................................................................................38 
8.7. 
Study Drug Handling and Disposal ............................................................................38 
9. 
STUDY PROCEDURES ............................................................................................39 
9.1. 
Medical History ..........................................................................................................39 
9.2. 
Physical Examinations ................................................................................................39 
9.3. 
Vital Signs ..................................................................................................................39 
9.4. 
Electrocardiograms .....................................................................................................39 
9.5. 
Laboratory Evaluations ...............................................................................................39 
9.6. 
Randomization ............................................................................................................41 
9.7. 
Pharmacokinetics, Pharmacogenomics, Exploratory Biomarkers, and Anti-
drug Antibodies ..........................................................................................................41 
9.8. 
Reactogenicity/Injection Site Inspection ....................................................................41 
9.9. 
Adverse Events ...........................................................................................................42 
9.10. 
Prior and Concomitant Medications and Concomitant Procedures ............................42 


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10. 
ASSESSMENT OF EFFICACY ................................................................................43 
11. 
ASSESSMENT OF SAFETY .....................................................................................44 
11.1. 
Safety Parameters .......................................................................................................44 
11.2. 
Adverse Events ...........................................................................................................44 
11.3. 
Adverse Event Reporting ............................................................................................44 
11.3.1. 
Notification of Serious Adverse Events .....................................................................44 
11.3.2. 
Notification of Emerging Safety Issues ......................................................................46 
11.4. 
Definitions ..................................................................................................................46 
11.4.1. 
Adverse Event .............................................................................................................46 
11.4.2. 
Suspected Adverse Reaction .......................................................................................46 
11.4.3. 
Life-Threatening AE or Life-Threatening Suspected Adverse Reaction ...................46 
11.4.4. 
Serious Adverse Event or Serious Suspected Adverse Reaction ................................47 
11.4.5. 
Unexpected AE or Unexpected Suspected Adverse Reaction ....................................47 
11.4.6. 
Adverse Events of Special Interest .............................................................................47 
11.4.7. 
Emerging Safety Issue ................................................................................................47 
11.4.8. 
Urgent Safety Measure ...............................................................................................48 
11.5. 
Adverse Event Classification ......................................................................................48 
11.5.1. 
Relationship to Study Drug ........................................................................................48 
11.5.2. 
Severity .......................................................................................................................48 
11.5.3. 
Serious Adverse Event ................................................................................................49 
11.6. 
Adverse Event Follow Up ..........................................................................................49 
11.7. 
Adverse Event Management .......................................................................................49 
11.8. 
Risks for Women of Childbearing Potential or During Pregnancy ............................49 
12. 
STATISTICAL METHODS .......................................................................................50 
12.1. 
Analysis Populations ..................................................................................................50 
12.2. 
Analysis of Study Population and Subject Characteristics .........................................50 
12.3. 
Safety Analyses ..........................................................................................................50 
12.4. 
Pharmacokinetic Analyses ..........................................................................................51 
12.5. 
Analyses of Pharmacogenomics, Exploratory Biomarkers, and Anti-Drug 
Antibodies ...................................................................................................................51 
12.6. 
Analyses of Respiratory Tract Infections ...................................................................51 
12.7. 
Interim Analysis ..........................................................................................................51 
12.8. 
Determination of Study Sample Size ..........................................................................52 


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12.9. 
Handling of Dropouts and Missing, Unused, and Spurious Data ...............................52 
12.10. 
Subject Disposition .....................................................................................................52 
12.11. 
Deviation Reporting ....................................................................................................52 
13. 
INVESTIGATOR REQUIREMENTS .......................................................................53 
13.1. 
Protocol Adherence ....................................................................................................53 
13.2. 
Electronic Case Report Forms ....................................................................................53 
13.3. 
Source Document Maintenance ..................................................................................53 
13.4. 
Study Monitoring Requirements .................................................................................53 
13.5. 
Study Completion .......................................................................................................53 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................55 
15. 
PROTECTION OF HUMAN SUBJECTS .................................................................56 
15.1. 
Informed Consent .......................................................................................................56 
15.2. 
IRB/IEC Approval ......................................................................................................56 
16. 
DATA HANDLING AND RECORD KEEPING ......................................................57 
16.1. 
Direct Access to Source Data/Documentation ...........................................................57 
16.2. 
Study Drug Accountability .........................................................................................57 
16.3. 
Retention of Records ..................................................................................................57 
16.4. 
Long-term Retention of Samples for Additional Future Research .............................58 
17. 
FINANCING AND INSURANCE .............................................................................59 
18. 
PUBLICATION POLICY ..........................................................................................60 
19. 
REFERENCES ...........................................................................................................61 
20. 
APPENDICES ............................................................................................................62 
APPENDIX 1. ACCEPTABLE METHODS OF CONTRACEPTION......................................63 
APPENDIX 2. ECG AND VITAL SIGN ABNORMALITIES .................................................64 
APPENDIX 3. DIAGNOSTIC CRITERIA AND MANAGEMENT FOR 
ANAPHYLAXIS ........................................................................................................65 
APPENDIX 4. RASH MANAGEMENT....................................................................................67 
APPENDIX 5. VISIT SCHEDULE FOR RASH MANAGEMENT FOR ADULT 
SUBJECTS .................................................................................................................72 
APPENDIX 6. INVESTIGATOR SIGNATURE .......................................................................74 
 
 


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2.1. 
LIST OF TABLES 
Table 1: 
Schedule of Events .....................................................................................................10 
Table 2: 
Dose Levels and Safety Margins (Animal-to-Human Dose Ratios) for the 
Proposed CD388 50 mg Dose.....................................................................................24 
Table 3: 
Study Design ...............................................................................................................27 
Table 4: 
Clinical Laboratory Tests ...........................................................................................40 
Table 5: 
Injection Site Evaluation .............................................................................................42 
Table 6: 
Table Guidelines for Assessing Relationship of Event to Study Drug .......................48 
Table 7: 
Guidelines for Severity Assessments ..........................................................................48 
 
 


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3. 
LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS 
OF TERMS 
Abbreviation 
Definition 
ADA 
anti-drug antibodies 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
AUC 
area under the plasma concentration-time curve 
AUC0–last 
area under the plasma (or nasopharyngeal) concentration-time curve from time 0 to 
time of last quantifiable sample 
AUC0- 
area under the plasma concentration-time curve from time 0 extrapolated to infinity 
BMI 
body mass index 
BSA 
body surface area 
CDC 
US Centers for Disease Control and Prevention 
CL/F 
apparent clearance  
Cmax 
maximum plasma (or nasopharyngeal) concentration 
COVID-19 
coronavirus disease 2019 
CrCL 
creatinine clearance 
CRU 
clinical research unit 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunosorbent assay 
Fc 
crystallizable fragment 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IgE 
immunoglobulin E 


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Abbreviation 
Definition 
IgG 
immunoglobulin G 
IgG1 
immunoglobulin G1 
IRB 
Institutional Review Board 
IVIg 
intravenous immunoglobulin 
MedDRA 
Medical Dictionary for Regulatory Activities 
NA 
neuraminidase 
NAI 
neuraminidase inhibitor 
NCA 
non-compartmental analysis 
NOAEL 
no-observed-adverse-effect level 
NP 
nasopharyngeal 
OTC 
over-the-counter 
PCR 
polymerase chain reaction 
PCS 
potentially clinically significant 
PEG 
polyethylene glycol 
PI 
Principal Investigator 
PK 
pharmacokinetic(s) 
PT 
Preferred Term 
RBC 
red blood cell(s) 
RTI 
respiratory tract infection 
SAE 
serious adverse event 
SAER 
Serious Adverse Event Report 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SJS 
Stevens-Johnson syndrome 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SQ 
subcutaneous 
t½ 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
TEN 
toxic epidermal necrolysis 
TM 
targeting molecule 
Tmax 
time to maximum plasma (or nasopharyngeal) concentration 


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Abbreviation 
Definition 
ULN 
upper limit of normal 
US 
United States 
VZ/F 
apparent volume of distribution 
WBC 
white blood cell(s) 
 


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4. 
BACKGROUND AND RATIONALE 
4.1. 
Background 
4.1.1. 
Influenza – Prevention and Treatment 
Globally, millions are hospitalized each year and about 650,000 deaths occur due to influenza 
(Iuliano 2018). In the United States (US), an estimated 37–43 million influenza-related illnesses, 
17– 20 million influenza-related medical visits, 500,000 to 650,000 influenza-related 
hospitalizations, and 61,000 deaths occurred during the 2018–2019 influenza season 
(Brammer 2019). These numbers remain high year after year because currently no effective 
medicine is available for the prevention of influenza. 
The US Centers for Disease Control and Prevention (CDC) recommends the administration of 
an influenza vaccine yearly for the prevention of influenza, but the efficacy varies yearly due to 
the emergence of new strains. According to the CDC, during the 2018–2019 influenza season, 
the vaccine was only 29% effective (Flannery 2019). Vaccines cannot offer complete protection 
because of high genetic diversity between and within influenza A and B types. Additionally, 
rapid antigenic drift and antigenic shift in the virus erodes vaccine durability (necessitating 
development of new vaccines annually), and slow vaccine manufacturing cycles make it difficult 
to keep pace with constantly mutating seasonal and pandemic viral strains. 
The neuraminidase inhibitors (NAIs) oral oseltamivir and inhaled zanamivir are approved for 
prophylaxis and treatment of acute uncomplicated influenza. Use of NAI antiviral prophylaxis is 
recommended to control institutional outbreaks of influenza when used within 48 hours after 
exposure in individuals who are not vaccinated or who are unlikely to respond to influenza 
vaccines and are immunosuppressed or have co-morbidities that predispose them to severe 
influenza illness. However, when NAIs are used for prophylaxis, even when used promptly 
after a known exposure, the efficacy is only around 70–80% and prolonged use in 
immunocompromised individuals can lead to the emergence of NAI drug resistance 
(Okoli 2014). 
Over the past 20 years there has been increasing concern that highly pathogenic avian strains 
such as H7N9 and H7N7 can be transmitted to humans causing high fatality rates in a manner 
similar to that of the H5N1 pandemic strain in 1997. Although the transmission of these avian 
strains to humans has been largely limited to individuals exposed to poultry, the possibility of 
the emergence of a highly pathogenic and human-adapted influenza variant is concerning 
(Paules 2017). Furthermore, recent modeling predicts that, in the event of a pandemic event 
along the lines of the 1918 Spanish flu, 33 million people would die in the first 6 months before 
a vaccine could be developed and many millions more would die during the time it would take 
for the global population to be immunized (Abbasi 2019). 
Progress towards a medicinal agent that provides protection against a broad range of influenza 
strains with a longer duration of protection, otherwise known as a “universal vaccine”, has been 
disappointing. The monoclonal antibody (mAb) therapeutics developed to date have suffered 
from limited spectrum and commercial limitations due to high dosing requirements and/or 
the need for multiple antibody cocktails to achieve a desired spectrum and efficacy. Thus, 
a significant unmet need exists for long-acting universal protective agents. 


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4.1.2. 
CD388 – A Long-Acting Antiviral Fc-Conjugate 
Cidara Therapeutics, Inc. (Cidara) is developing a novel therapeutic and prophylactic agent that 
has a potential to provide durable single-dose “universal” coverage per flu season. Cidara has 
replaced variable domains of a monoclonal antibody with multiple copies of a highly potent 
small molecule antiviral agent (the marketed NAI zanamivir) tailored to target a small, highly 
conserved essential influenza target. This molecule, CD388, is a first in class long-acting 
antiviral Fc-conjugate (AVC) combining a surface-acting antiviral agent with the crystallizable 
fragment (Fc) of a human immunoglobulin G1 (IgG1) antibody. 
CD388 differs from traditional antibody-drug conjugate (ADC) molecules in the following 
aspects: 
x In traditional antibody-drug conjugates the drug is attached to full length human IgG 
(Fc + antigen-binding fragment [Fab]); in contrast, zanamivir dimers of CD388 are 
conjugated to an Fc fragment of human IgG1 (and not full length IgG1). 
x In traditional antibody-drug conjugates the drug is conjugated to the human IgG using 
a protease-cleavable linker to allow release of the drug inside target cells; the linker 
between zanamivir and the Fc in CD388 is not a substrate for proteases, and it exerts its 
antiviral activity in the extracellular space. 
x Traditional antibody-drug conjugates are used to treat cancer by delivering cytotoxic 
payloads to target cells with rapid release; CD388 is designed to treat and prevent 
infectious disease using a long-acting stable conjugate of a non-cytotoxic small molecule 
to an Fc fragment of IgG1 
In nonclinical in vitro and in vivo models, CD388 has demonstrated the potential for 
significantly higher antiviral activity and efficacy compared to the parent molecule, zanamivir, 
as well as other NAIs, including oseltamivir. 
4.1.2.1. 
CD388 Nonclinical Studies 
Several in vitro and in vivo nonclinical studies have been conducted to evaluate the safety 
and efficacy of CD388 and/or related Fc-conjugated prototype targeting molecules (TMs) to 
support dosing in humans. In vitro NAI and cell-based assays were conducted with CD388 to 
assess its spectrum and potency against Wild Type (WT) as well as drug-resistant influenza 
strains. In vitro studies to characterize the extent of neonatal crystallizable fragment receptor 
(FcRn) and Fc-Ȗ receptor binding across different species were conducted. In vitro studies to 
characterize the potential for resistance development with CD388 have been undertaken. In vivo 
efficacy of CD388 was observed in treatment, and prophylaxis or preventative mouse lethal 
infection models. 
,QYLWURVWDELOLW\RIWKH70FRPSRXQGDORQHZDVTXDQWLWDWLYHO\WHVWHGDWႏLQSKRVSKDWH-
buffered saline, plasma, and liver microsomes. Stability of the intact Fc-conjugated molecule, 
CD388, was qualitatively observed in liver miFURVRPHVDWႏ,QYLYRWKHpharmacokinetics 
were investigated in animal species that were used to characterize the pharmacological 
and toxicological profile of CD388 and related molecules; namely in mouse, rat, and monkey. 
More importantly, following pharmacokinetic studies in the mouse, rat, and monkey, plasma 
concentrations were quantified by a neuraminidase (NA)-capture or Fc-capture with Fc detection 


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enzyme-linked immunosorbent assay (ELISA) methods, to confirm the stability of CD388 in 
vivo. NA-capture/Fc-detection measures the concentration of intact NA-linked-Fc species while 
Fc-capture/Fc-detection measures the total concentration of Fc-related species. Plasma 
concentrations measured by both methods were comparable, suggesting that intact CD388 
remained stable in vivo as designed. 
Single-dose, range-finding intramuscular (IM) and/or subcutaneous (SQ) toxicity 
and toxicokinetic studies, with endpoint evaluations occurring over the plasma exposure 
periods of 4 weeks in rats and 6 weeks in monkeys, have been conducted. The pivotal Good 
Laboratory Practice (GLP) toxicity studies include endpoints to assess safety pharmacology 
(i.e., cardiovascular, respiratory, and neurobehavioral effects) and toxicokinetics to determine 
safety margins. In addition, screening for anti-CD388 antibodies, cytokine analysis, 
and immunophenotyping have been performed. These pivotal GLP nonclinical studies 
supporting first-in-human (FIH) studies were designed in accordance with the relevant 
International Council for Harmonisation (ICH) guidance and US Food and Drug Administration 
(FDA) guidance on safety and toxicology studies for CD388’s predecessor molecule (CD377). 
Refer to the Investigator’s Brochure for additional nonclinical information. 
4.1.2.2. 
CD388 Clinical Studies 
In an ongoing study (CD388.IM.SQ.1.01), the safety and tolerability of CD388 is being 
evaluated in Western healthy adult subjects, examining CD388 administered either 
intramuscularly or subcutaneously.  
Regular assessment of blinded safety/tolerability data from 33 healthy subjects who received 
a dose of 50 mg, 150 mg, or 450 mg of subcutaneous CD388 or placebo has not identified any 
concerning safety observations to date. 
All treatment-emergent adverse events (TEAEs) have been Grade 1 or Grade 2 (mild or 
moderate) in severity, with headache being the most frequently occurring (27.3% subjects), none 
of which occurred in the higher dose group (150 mg) as of the first Interim Analysis in the FIH 
study. Since then, preliminary safety data generated from the 450 mg dose group indicated that 
the safety and tolerability profile remained unchanged. 
Of note, as of the first interim analysis in the FIH study, all TEAEs in the higher dose group (150 
mg) have been Grade 1. No serious adverse events (SAEs) have occurred, and no drug-related 
TEAEs have resulted in clinically significant hematology or chemistry laboratory abnormalities. 
No safety issues associated with electrocardiograms (ECGs), vital signs, or physical examination 
findings (including local injection site reactions) have been identified. No safety findings have 
resulted in discontinuation or study drug or withdrawal from study. Preliminary safety data 
generated from the 450 mg dose group indicated that the safety and tolerability profile remained 
unchanged. 
4.2. 
Summary of Benefits and Risks 
A brief summary of clinical and nonclinical data is presented in Section 4.1.2. 
The risks for the individual subject due to administration of CD388 Injection are considered low 
and are outweighed by the potential to develop a new treatment in an area of high unmet medical 
need. To further minimize any potential risk, all subjects will be closely screened for any 


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underlying conditions that may increase risk of study participation. During the conduct of the 
study, subjects are housed in a clinical research unit (CRU) for 14 days after CD388 
Injection/placebo administration, under continuous medical supervision.  
4.3. 
Justification of Dose 
The dose(s) planned for this study are based on results obtained from the FIH clinical study, GLP 
3-month exposure toxicology studies in rats and primates, and the FDA’s guidance contained in 
“Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult 
Healthy Volunteers” (FDA 2005). 
From the 3-month GLP toxicology studies in rats and monkeys, a no-observed-adverse-effect 
level (NOAEL) of 500 mg/kg has been established for both species. CD388 safety margins 
generated from these pivotal 3-month exposure studies in support of the dose are presented in 
Table 2. At the 50 mg human dose administered as a bolus SQ injection, the safety margin based 
on the 3-month NOAELs and using body surface area (BSA) is 97-fold in rats and 194-fold in 
monkeys. Safety margins based on human area under the plasma concentration-time curve 
(AUC) predictions at 50 mg relative to the rat and monkey 3-month plasma AUC exposures are 
166-fold in rats and 581-fold in monkeys. 
Table 2: 
Dose Levels and Safety Margins (Animal-to-Human Dose Ratios) for the 
Proposed CD388 50 mg Dose 
3-Month Pivotal 
Toxicity 
Studies c 
Animal Dose or Plasma Levels 
at NOAEL a 
Safety Margins for 50 mg Human Dose 
Animal-to-Human Ratios b 
mg/kg 
mg/m2 d 
AUC 
(μg×h/mL) e 
Cmax 
(μg/mL) 
Based 
on BSA 
Based on 
Predicted 
Plasma AUC f 
Based on 
Predicted 
Plasma Cmax f 
Rat 
500 
3000 
641,000 
1190 
97-fold 
166-fold 
83-fold 
Monkey 
500 
6000 
2,240,000 
3390 
194-fold 
581-fold 
235-fold 
Abbreviations: AUC = area under the plasma concentration-time curve; AUC0–3month = area under the plasma concentration-
time curve from time 0 to 3 months; AUC0- = area under the plasma concentration-time curve from time 0 extrapolated to 
infinity; BSA = body surface area; Cmax = maximum plasma concentration; FIH = first-in-human; IM = intramuscular; 
IV = intravenous; NOAEL = no-observed-adverse-effect level; PK = pharmacokinetic; SQ = subcutaneous. 
a. NOAEL in rat and monkey 3-month studies. 
b. Safety margins based on the proposed FIH dose of 50 mg or 0.833 mg/kg based on a 60 kg person, and 31 mg/m2 based on 
a 1.62 m2 person (FIH Guidance). 
c. Repeat dose NOAEL from pivotal 3-month toxicity studies (NC CD388-004, NC-CD388-003). 
d. The mg/m2 dose was derived by multiplying mg/kg by 6 (rat) or 12 (cynomolgus monkey) (FIH Guidance). 
e. Mean AUC0–3month values (males and females combined) calculated over 3 months: rat by summing AUC from 3 doses 
and monkey by summing AUC from 2 doses, to cover a 3-month exposure period. 
f. Predicted human plasma PK for 50 mg starting dose (or 0.833 mg/kg based on a 60 kg person): AUC0-  JîKP/
Cmax = 14.4 g/mL (calculated from 5 mg/kg IV human PK as reported/projected in NC-CD388-05). Note: These 
exposures were predicted for IV administration and would represent the highest values expected as bioavailability from IM 
or SQ administration is anticipated to be approximately 70% of IV based on animal PK studies, potentially lowering the 
exposures in human from IM or SQ dosing. 
 
Safety results of the ongoing clinical trial CD388.IM.SQ.1.01 have indicated no significant 
safety findings following single SQ administration of 50, 150 mg, and 450 mg CD388. 


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In summary, excellent safety margins were achieved with CD388 in 3-month toxicity studies 
relative to the FIH human dose conservatively scaled to BSA and to the predicted FIH plasma 
exposure. Although no adverse findings were identified in nonclinical studies, transient minor 
changes in clinical pathology parameters were observed in the absence of other changes, 
including no changes in cytokines and microscopic findings, and no CD388-related effects on 
kidney or the reticuloendothelial system. The outcome of the CD388 nonclinical safety program 
supports the proposed clinical program and dose of 50 mg, 150 mg, and 450 mg administered as 
bolus SQ injections. Results from the FIH study to date have shown no significant safety 
findings after 50 mg, 150 mg, and 450 mg CD388 administrations. 
4.4. 
Population to be Studied 
Healthy adult Japanese subjects. 
4.5. 
Rationale for Trial Endpoints 
The measures for evaluation of the safety and tolerability profile of CD388 Injection are standard 
for most clinical studies and follow the recommendations in the ICH guidelines. The assessments 
for determining the plasma concentrations are appropriate to characterize the pharmacokinetic 
(PK) profile of CD388. 
Exploratory biomarkers, anti-drug antibodies, and pharmacogenomic research are exploratory in 
nature and do not have pre-defined endpoints. 
4.6. 
Statement of Compliance 
This study will be conducted in compliance with the protocol, International Council for 
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 
(ICH) E6 Good Clinical Practice (GCP), and applicable regulatory and IRB requirements. 


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5. 
STUDY OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
 
x To determine the safety and tolerability 
profile of CD388 Injection when dosed by 
subcutaneous (SQ) administration as 
a single dose to healthy Japanese adult 
subjects. 
x Incidence and severity of treatment-emergent 
adverse events (TEAEs), including but not 
limited to adverse events (AEs) and serious 
adverse events (SAEs) (including systemic 
reactogenicity/injection site reactions and 
hypersensitivity reactions), AEs leading to study 
drug discontinuation and/or study withdrawal, 
vital signs, 12-lead electrocardiograms (ECGs), 
and clinical laboratory tests (including 
hematology, coagulation, serum chemistry, 
and urinalysis), after a single dose of CD388. 
Secondary 
 
x To determine the plasma pharmacokinetic 
(PK) profile of CD388 Injection when 
dosed by SQ administration as a single dose 
to healthy Japanese adult subjects. 
x Pharmacokinetic parameters following CD388 
Injection administration: maximum plasma 
concentration (Cmax), time to maximum plasma 
concentration (Tmax), terminal elimination 
half-life (t½), apparent clearance (CL/F), 
apparent volume of distribution (VZ/F), area 
under the plasma concentration-time curve from 
time 0 to time of last quantifiable sample 
(AUC0-last), area under the plasma concentration-
time curve from time 0 extrapolated to infinity 
(AUC0-). 
Exploratory 
x To evaluate the PK profile of CD388 in 
upper respiratory tract after SQ 
administration as a single dose to healthy 
Japanese adult subjects. 
x Pharmacokinetic parameters following CD388 
Injection administration: maximum 
nasopharyngeal (NP) concentration (Cmax), time 
to maximum NP concentration (Tmax), area under 
the NP concentration-time curve from time 0 to 
time of last quantifiable sample (AUC0-last). 
x To evaluate biomarkers that may be 
associated with safety, reactogenicity, and 
immunogenicity after CD388 Injection. 
x Results of the analyses of exploratory 
biomarkers (including but not limited to 
cytokines, chemokines, acute phase reactants, 
etc.). 
x To evaluate CD388 immunogenicity. 
x Anti-drug antibody (ADA) titers in blood 
(plasma or serum). 
x To explore the effect of CD388 Injection on 
the occurrence of influenza-like illness 
(during flu season). 
x Occurrence of influenza-like illness reporting 
during the outpatient follow-up period. 
 


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6. 
STUDY DESIGN 
6.1. 
Description of the Study 
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single 
doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals are to 
assess safety, tolerability, and PK of CD388.  
Subjects will be randomized to receive a single dose of CD388 or placebo administered via SQ 
injection (treatment assignment is blinded) according to the design in Table 3. 
Table 3: 
Study Design 
Number of Subjects (N = 27) 
Cohort: dose 
CD388 
(n = 21) 
Placebo 
(n = 6) 
Cohort 1: 50 mg 
7 
2 
Cohort 2: 150 mg 
7 
2 
Cohort 3: 450 mg 
7 
2 
Note: A subject may not receive treatment in more than one cohort. 
After 50% of Cohort 1 subjects have completed study drug administration and have undergone 
protocol-specified procedures and DVVHVVPHQWVIRU10 days, the Principal Investigator (PI) 
and Sponsor will review blinded safety data: AEs (including systemic reactogenicity/injection 
site reactions, hypersensitivity reactions, and adverse events of special interest [AESIs]), vital 
signs, 12-lead ECGs, and clinical laboratory results (hematology, coagulation, serum chemistry, 
urinalysis) to determine the safety and tolerability of the study drug. The incidence and severity 
of AEs, and any adverse changes in vital signs, clinical laboratory findings, and ECGs will be 
considered when determining safety and tolerability of study drug. If the dose is determined to be 
VDIHDQGZHOOWROHUDWHG10 days after dosing, Cohort 2 will be enrolled. Enrollment of the 
remaining 50% of Cohort 1 will continue while the safety data of the first 50% of Cohort 1 is 
being reviewed. Similar processes will be followed for dose escalation from Cohort 2 to 
Cohort 3. 
The Schedule of Events is presented in Table 1. All subjects will be admitted to the clinical 
research unit (CRU) for observation and safety assessments from Day -1 (check-in) to Day 14. 
Subjects will be monitored for AEs (including systemic reactogenicity/injection site reactions, 
hypersensitivity reactions, and AESIs) and SAEs throughout the study until the final study visit 
after dosing. Safety will also be assessed by physical examinations, ECGs, vital signs 
measurements, and laboratory evaluations (hematology, coagulation, serum chemistry, 
urinalysis) at various time points during and after the CRU stay. Concomitant medication use 
will be recorded throughout the study.  
Blood samples for PK and ADA assessments will be collected throughout the study. To maintain 
the blind, samples will be collected from all subjects; however, only samples from the CD388 
Injection group will be analyzed (using validated assays) by an unblinded central bioanalytical 
laboratory. Additional blood samples will be collected for pharmacogenomics and exploratory 
biomarker evaluation. 


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Respiratory tract infection (RTI) surveillance will be conducted during the outpatient phase of 
the study from CRU discharge through the Day 120/165 outpatient visit or a lab-confirmed 
influenza infection, whichever occurs first. Subjects will be provided nasal/throat swab kits (for 
detection of influenza infection or other respiratory pathogen by a multiplexed polymerase chain 
reaction [PCR] test) and symptom diary cards.  
If 3 or more RTI symptoms listed in the table below occur (at least one must be a respiratory 
symptom), subjects will contact study staff, then collect nasal/throat swab samples (the swabs 
should take place as soon as possible after the start of symptoms, ideally within 48 hours, but no 
later than 5 days). Subjects will complete symptom diary cards every 7 days to capture the worst 
grade of symptoms that occurred during the previous week. The Investigator/study staff will 
arrange for prompt shipment of the nasal/throat samples to the testing laboratory. Note: If the 
reported symptoms are already of a level of severity that urgent care is indicated, the subject 
should be directed to the appropriate facility to receive this care (e.g., emergency room). 
Otherwise, symptoms should be treated according to standard of care. 
If an influenza infection is confirmed by the testing laboratory before the Day 120/165 outpatient 
visit, the event should be documented until all symptoms have resolved, including completion of 
the symptom diary card every 7 days. Thereafter, no further RTI surveillance will be carried out 
on the subject.  
If the nasal/throat swab samples are not confirmed to be influenza by the testing laboratory, diary 
card completion will continue through the Day 120/165 outpatient visit.  
Respiratory Tract Infection (RTI) Symptoms 
x 
Runny nose (rhinorrhea) 
x 
Shortness of breath (dyspnea) 
x 
Stuffy nose (nasal congestion) 
x 
Wheeze 
x 
Sore throat 
x 
Chilliness/feverishness or temperature °F 
x 
Earache 
x 
Headache 
x 
Cough 
x 
Body ache 
x 
Productive phlegm/sputum 
 
As part of the surveillance, subjects will be questioned during all outpatient site visits for RTI 
symptoms. If the interval to the next outpatient site visit exceeds 15 days, subjects will be 
contacted by the Investigator/study staff every 2 weeks to query for RTI symptoms. Subjects 
should be reminded to contact the Investigator/study staff if RTI symptoms occur, and to collect 
the nasal/throat swab samples and complete the symptom diary cards every 7 days. 
6.2. 
Criteria for Evaluation 
6.2.1. 
Safety and Tolerability of Study Drug 
Safety and tolerability will be assessed by monitoring AEs (including systemic reactogenicity/
injection site reactions, hypersensitivity reactions, and AESIs), vital signs, 12-lead ECGs, 
clinical laboratory results (hematology, coagulation, serum chemistry, urinalysis), 
and concomitant medication usage throughout the study.  
See Section 6.1 for details regarding cohort/dose level enrollment timing and assessment of 
safety and tolerability for dose escalation decision. 


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If a dose level is considered not safe or well tolerated, the study drug assignment for the 
subject(s) with the safety issue may be unblinded. The Sponsor may also independently decide to 
unblind the entire cohort for safety concerns or terminate enrollment for any reason. 
,IDQ\VXEMHFWGHYHORSVD*UDGH$(or an SAE of any grade that is deemed related to the 
study drug, the mechanism of the AE may be assessed (i.e., cytokine level, complement 
activation, immunoglobulin G [IgG] subtypes, immunoglobulin E [IgE], T-cell/B-cell/monocyte 
and basophil activation as assessed by flow cytometry, ADA development, and immune complex 
formation) at Sponsor and Investigator discretion, and the study dose may be modified for the 
remainder of the study. 
6.2.2. 
Pharmacokinetics/Anti-drug Antibodies 
Pharmacokinetics will be determined by analyzing plasma samples for concentration of CD388 
obtained from subjects who receive CD388 Injection in each cohort at various time points after 
administration of study drug. Anti-drug antibodies will also be measured at selected time points 
by a validated ELISA method. 
6.2.3. 
Pharmacogenomics 
A mandatory pharmacogenomic (DNA) blood sample will be collected once, preferably on 
Day 1 (collection at another time point is permitted if necessary) to allow for genetic research to 
help understand the characteristics of CD388. Genetic analysis will be conducted if it is 
hypothesized that doing so may aid in exploring genetic markers which could explain differences 
in safety, immunogenicity, or clinical response among subjects. Host DNA assessment will be 
limited to research related to CD388, including the development of tests/assays related to CD388 
and flu-like disease. 
Analyses of host DNA may be conducted at the Sponsor’s discretion and reported separately 
from the study report. 
6.2.4. 
Exploratory Biomarkers 
Blood samples will be collected to allow for the exploration of biomarkers on the assumption 
that these markers could play a role in the response (safety, reactogenicity, immunogenicity) to 
CD388. 
These samples and remaining material from other samples may be used for further assay 
optimization/qualification, biomarkers, or further exploratory analyses. Samples will only be 
used for research related to influenza virus infection, flu-like disease, and safety, reactogenicity, 
and immunogenicity of CD388, including the development of tests/assays related to CD388 
and influenza. 
Analyses of biomarkers may be conducted at the Sponsor’s discretion and reported separately 
from the study report. 
6.3. 
Number of Subjects 
A total of 27 healthy volunteers will be enrolled in this study in 3 cohorts: 9 of the 27 subjects 
will be enrolled in the first cohort and randomized in a 7:2 ratio to receive either 50 mg CD388 
SQ injection or matching placebo injection; the remaining subjects will be enrolled in the second 


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and third cohorts (9 subjects each) and randomized in a 7:2 ratio to receive either 150 mg 
(Cohort 2) or 450 mg (Cohort 3) CD388 SQ injection or matching placebo injection.  
6.4. 
Measures Taken to Minimize Bias 
Study drug assignment (CD388 Injection or placebo) will be blinded to all blinded clinical site 
and Sponsor study team until at least after the final subject in a cohort has completed the Day 90 
visit. Unblinded personnel include the site pharmacist (or pharmacist designee) preparing the 
injections, the unblinded pharmacy monitor (to ensure study drug accountability and assignment 
throughout the trial), and the Sponsor’s unblinded team. 
6.5. 
Expected Duration of Subject Participation 
A single dose of study drug will be administered SQ on Day 1. Study participation will require 
up to 28 days for screening procedures, and approximately 120/165 days for dosing and follow-
up (check-in to the CRU on Day -1; CRU inpatient stay for study drug administration, 
observation, and assessments and procedures for 15 days [Days -1 to Day 14]; and 5 CRU 
outpatient visits for additional assessments and procedures). 
6.6. 
Method of Treatment Assignment and Blinding 
After informed consent has been obtained, subjects will be screened for study eligibility before 
randomization. 
Within each dose level (Cohorts 1, 2, and 3), subjects will be randomized to receive a single dose 
of CD388 Injection or saline placebo (treatment assignment is blinded). The study site’s 
pharmacist (or pharmacist designee) will obtain a computer-generated study drug assignment. 
A subject is considered randomized when a randomization transaction is appropriately recorded. 
Unless a formal interim analysis is conducted after all subjects have completed the Day 90 visit, 
all blinded study personnel (including the Sponsor, Investigator, and site personnel directly 
involved in study conduct) and subjects will remain blinded to study drug assignment until the 
study is completed and the final database is locked with the exception of the unblinded pharmacy 
personnel, pharmacy monitor, and unblinded Sponsor personnel (such as Data Review 
Committee, clinical supply manager, PK lead, and quality manager) who may be unblinded to 
study medication at any time during study conduct. The pharmacy monitor will monitor study 
drug preparation and accountability during the study and cases in which unblinding is required 
due to a safety or tolerability issue. To maintain study blinding, study drug preparation will be 
performed by an unblinded site pharmacist (or qualified unblinded personnel at the study site not 
involved with study procedures or evaluations). Any unblinding related to an interim analysis 
will be documented in the blinding plan. 
Instructions for study drug preparation and dosing are outlined in the Pharmacy Manual provided 
separately to the site. In the event of a medical emergency requiring the Investigator to know the 
identity of the study drug, the Investigator will follow the procedures outlined in Section 8.4. 
6.7. 
Data Review Committee 
A Sponsor Data Review Committee, consisting of representatives of the Sponsor not involved in 
day-to-day management of the study, may be established to review unblinded data to allow 


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strategic development decisions within and across development programs. The procedures of the 
Data Review Committee will be documented in a charter. 


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7. 
SELECTION, DISCONTINUATION, AND WITHDRAWAL OF 
SUBJECTS 
7.1. 
Subject Inclusion Criteria 
Subjects must meet ALL the following inclusion criteria: 
1. Must be of Japanese descent with Japanese parents and grandparents, as determined by 
subject's verbal report. 
2. Willing and able to provide written informed consent. 
3. Males and females 18 to 65 years of age, inclusive. 
4. A female subject must meet one of the following criteria: 
a. If of childbearing potential – agrees to use a highly effective, preferably 
user-independent method of contraception (failure rate of <1% per year when used 
consistently and correctly) for at least 30 days prior to screening and agrees to remain 
on a highly effective method until 7 months after last dose of study medication. 
Examples of highly-effective methods of contraception are located in Appendix 1.  
b. If a female of non-childbearing potential – should be surgically sterile (i.e., has 
undergone complete hysterectomy, bilateral oophorectomy, or tubal 
ligation/occlusion without reversal surgery) or in a menopausal state (at least 1 year 
without menses), as confirmed by follicle-stimulating hormone (FSH) levels 
 mIU/mL). 
5. A woman of childbearing potential must have a negative highly sensitive serum 
SUHJQDQF\WHVWȕ-human chorionic gonadotropin) at screening and a negative urine 
pregnancy test on Day -1 before the first dose of study drug. 
6. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the study and for a period of at least 7 months after study drug 
administration. 
7. A male subject that engages in sexual activity that has the risk of pregnancy must agree to 
use a double barrier method (e.g., condom and spermicide) and agree not to donate sperm 
during the study and for at least 7 months after the last dose of the study medication. 
8. Good health and without signs or symptoms of current illness. 
9. Normal clinical examination, including: 
a. No physical examination findings that an Investigator determines would interfere 
with interpretation of study results. 
b. Screening ECG without clinically significant abnormalities (see Appendix 2).  
c. Creatinine clearance (CrCL) mL/min as calculated using the Cockcroft-Gault 
equation: 
ܥݎܥܮ= 
(140 െܽ݃݁) × (ݓ݄݁݅݃ݐ ݅݊ ݇݃)
72 × (ݏ݁ݎݑ݉ ܿݎ݁ܽݐ݅݊݅݊݁ ݅݊ ݉݃/݀ܮ) × (0.85 ݂݅ ݂݈݁݉ܽ݁) 


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d. Negative urine screen for drugs of abuse and alcohol at screening and Day -1. 
10. Body weight 50 kg and body mass index between 18.0 and 30.0 kg/m2, inclusive, using 
the following equation: 
ܤܯܫ=
(ݓ݄݁݅݃ݐ ݅݊ ݇݃)
(݄݄݁݅݃ݐ ݅݊ ݉݁ݐ݁ݎݏ)ଶ 
11. Willing to refrain from strenuous physical activity that could cause muscle aches 
or injury, including contact sports, at any time from screening through 30 days after any 
dose of study drug. 
12. Subject has adequate venous access for blood collection. 
7.2. 
Subject Exclusion Criteria 
Subjects must NOT meet any of the following exclusion criteria: 
1. History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase 
inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 
Injection drug formulation; or history of drug-induced exfoliative skin disorders 
(e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal 
necrolysis [TEN]). 
2. History of any of the following: 
a. Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, 
polyethylene glycol [PEG], etc.). 
b. Chronic immune-mediated disease, positive first-degree family history of 
autoimmune diseases. 
c. Atopic dermatitis or psoriasis. 
d. Bleeding disorder. 
e. Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for 
mental conditions. 
f. Migraines. 
g. Syncope, or vasovagal syndrome with injections or blood draws. 
h. Cardiac arrythmia considered clinically significant by the Investigator. 
3. Subjects with one or more of the following laboratory abnormalities at screening as 
defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse 
Events v2.1 (DAIDS 2017): 
a. 6HUXPFUHDWLQLQH*UDGHîXSSHUOLPLWRIQRUPDO>8/1@. 
b. 3DQFUHDWLFDP\ODVHRUOLSDVH*UDGHî8/1. 
c. $VSDUWDWHDPLQRWUDQVIHUDVH$67RUDODQLQHDPLQRWUDQVIHUDVH$/7*UDGH
î8/1. 
d. 7RWDOELOLUXELQ*UDGHî8/1. 


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e. $Q\RWKHUWR[LFLW\*UDGHH[FHSWIRU*UDGHHOHYDWLRQVRIWULJO\FHUides, low 
density lipoprotein cholesterol, and/or total cholesterol. 
f. Any other laboratory abnormality considered to be clinically significant by the 
Investigator. 
Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed 
once without prior asking approval from the Sponsor. Retesting will take place during a 
scheduled or unscheduled visit during screening. Subjects with a normal value at retest 
may be included. 
4. Alcohol or drug addiction in the past 2 years. 
5. Experiencing symptoms of acute illness or chronic disease within 14 days prior to clinical 
research unit (CRU) check-in. 
6. At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus 
antibody, or human immunodeficiency virus (HIV) antibody. 
7. A positive result at CRU check-in for severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) by polymerase chain reaction (PCR). 
8. Unwilling to comply with local health policy effective at the time regarding coronavirus 
disease 2019 (COVID-19). Full COVID-19 vaccination prior to participation is strongly 
recommended. 
9. Women who are pregnant or nursing. 
10. Received any over-the-counter (OTC) medications or nutritional supplements within 
7 days, or any prescription medications within 14 days or <5 half-lives prior to dosing, 
whichever is longest (except for hormonal contraceptives, acetaminophen, or ibuprofen). 
11. Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening. 
12. Received any vaccines or immunoglobulins within 28 days prior to dosing (90 days in 
case of intravenous immunoglobulin [IVIg] or biologics, or 14 days for COVID-19 
vaccine). 
13. Donated blood (within 56 days of screening) or plasma (within 7 days of screening) 
or experienced significant blood loss or significant blood draw (blood donation or blood 
loss of 500 mL) when participating in non-interventional clinical trials within 30 days 
prior to dosing. 
14. Received a blood transfusion within 28 days prior to dosing. 
15. Received any biologics within 90 days prior to dosing; or previous participation in 
another study (including investigational device studies) within 30 days of dosing 
or 5 half-lives of the study drug, whichever is longer, prior to screening (prior 
participation at any time in non-invasive methodology trials in which no drugs were 
given is acceptable). 
16. Previous treatment with CD388. 
17. Preplanned surgery at any time during the study. 


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18. The Principal Investigator (PI) considers that the volunteer should not participate in the 
study. 
7.3. 
Requalification for Entry 
Subjects not fulfilling the entry criteria and not randomized may be rescreened for participation 
with the approval of the Sponsor Medical Monitor. A subject who rescreens will receive a new 
screening number. 
7.4. 
Subject Withdrawal Criteria 
7.4.1. 
Withdrawal from Study Protocol 
Subjects may withdraw consent to participate in this study at any time without penalty or loss of 
benefits to which the subject is otherwise entitled. Subjects who wish to withdraw completely 
from this clinical study should be encouraged to complete the Day 120/165 assessments. Every 
reasonable effort should be made to determine the reason a subject withdraws prematurely, 
and this information should be recorded on the appropriate page(s) of the electronic case report 
form (eCRF). 
Subjects may be withdrawn from the study for any of the following reasons: 
x Subject is unable or unwilling to continue 
x Subject elects to withdraw informed consent 
x Adverse event (whether or not related to study drug) that precludes further participation 
in the study in the judgment of an Investigator and/or Sponsor 
x Protocol non-compliance 
x Subject lost to follow-up, or follow-up is not possible 
x The Investigator considers that it is in the subject’s best interest not to continue 
participation in the study 
If a subject is removed from the study for any reason, the subject will be followed for resolution 
of any ongoing AE(s). 
7.5. 
Replacement of Subjects 
Subjects who are withdrawn for reasons other than AEs may be replaced at the discretion of the 
Sponsor into the same cohort and blinded treatment assignment as the replaced subject. 
7.6. 
Temporary Study Halt for Safety Review 
The study will be temporarily halted, pending review of available data, if any of the following 
occur:  
x ,IVXEMHFWVH[SHULHQFHWKHVDPH*UDGH$(HYHQWRUODERUDWRry abnormality within 
28 days after study drug administration, considered attributable to CD388 or cannot be 
attributed to another cause 


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x ,IVXEMHFWH[SHULHQFHVD*UDGH$(RUODERUDWRU\DEQRUPDOLW\ZLWKLQGD\VDIWHU
study drug administration, considered attributable to CD388 or cannot be attributed to 
another cause 
x ,IVXEMHFWH[SHULHQFHVDQ6$(irrespective of toxicity grade within 28 days after study 
drug administration, considered attributable to CD388 or cannot be attributed to another 
cause 
If it is considered appropriate to restart the study following an internal safety review, 
an amendment, if required, will be submitted to the FDA and IRB. The study will not restart until 
the amendment has been approved by the FDA and IRB. 
7.7. 
Study Termination by Sponsor and Termination Criteria 
The Sponsor reserves the right to terminate an investigational site or this clinical study at any 
time. Reasons for termination may include, but are not limited to, the following: 
x The incidence or severity of AEs indicate a potential health hazard to subjects. 
x Serious or persistent noncompliance by the Investigator with the protocol, clinical 
research agreement, or applicable regulatory guidelines in conducting the study. 
x Institutional Review Board (IRB)/Independent Ethics Committee (IEC) decision to 
terminate or suspend approval for the investigation or the Investigator. 
x Investigator request to withdraw from participation. 
x Subject enrollment is unsatisfactory. 


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8. 
STUDY DRUG 
8.1. 
CD388 Injection 
CD388 Injection is a clear to lightly opalescent liquid essentially free of particulate matter 
containing the active pharmaceutical ingredient, CD388. CD388 Injection is supplied as a frozen 
sterile solution in single-use vials. Refer to the Pharmacy Manual for details. 
CD388 Injection is administered by SQ injection at the doses described in Table 3. Dose levels 
to be assessed will follow an ascending single-dose regimen with the starting dose based on 
findings from 3-month rat and monkey toxicology studies. 
8.1.1. 
Directions for Use 
CD388 Injection should be thawed at room temperature over 30 minutes (not to exceed 24 hours) 
prior to drawing the dose from the vial into the syringe. 
After CD388 Injection is drawn from the vial into the syringe, it must be administered within 
4 hours. 
8.1.2. 
Drug Storage 
Vials of CD388 Injection are stored frozen at -20°C. 
8.1.3. 
Dose Adjustment 
Dosage adjustments of CD388 Injection in individual subjects are not allowed in this study. 
8.2. 
Placebo Injection 
Normal saline will be administered SQ as the placebo control. 
8.3. 
Compliance 
Treatment compliance for CD388 Injection/placebo will be documented in the eCRF by 
recording the date, administration time, and the volume of the dose of study drug administered. 
8.4. 
Breaking the Blind 
The study is a double-blind design. The Sponsor, Investigator, study site personnel, and subjects 
will not make any effort to determine which blinded study drug (CD388 Injection or placebo) is 
administered. Unblinded pharmacy personnel will be responsible for preparing syringes such that 
the double-blind is maintained. 
Only in the case of an emergency, when knowledge of the study drug is essential for the clinical 
management or welfare of a specific subject, may the Investigator unblind a subject’s study drug 
assignment. 
As soon as possible and without revealing the subject’s study drug assignment (unless important 
to the safety of subjects remaining in the study), the Investigator must notify the Sponsor if the 
blind is broken for any reason. The Investigator will record in source documentation the date 
and reason for revealing the blinded study drug assignment for that subject. 


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As PK samples from subjects assigned to placebo treatment will not be analyzed for 
determination of CD388 concentrations, the bioanalytical laboratory will receive the 
randomization list to allow for correct selection of the samples. Unblinding of the randomized 
treatment assignment will be performed at the bioanalytical laboratory. Specific procedures will 
be in place to ensure that randomized treatment assignment will not be revealed to anyone 
involved in the execution of the study. 
8.5. 
Previous and Concomitant Medications and Substances 
All medications administered within 28 days prior to study drug administration and throughout 
the study will be documented and recorded in the eCRF. 
Subjects must refrain from OTC, herbal medications, and nutritional supplements within 7 days 
and prescription medications within 14 days or <5 half-lives before first study drug 
administration, and until after the final study visit (except for hormonal contraceptives, 
acetaminophen, or ibuprofen). The Investigator should consult the Sponsor’s Medical Monitor 
for guidance regarding other medication or vaccine usage during the study. 
8.6. 
Accountability Procedures 
The pharmacy or study personnel are responsible for ensuring that a current record of CD388 
Injection inventory and accountability are maintained.  
A Pharmacy Monitor will be responsible for checking drug accountability at the site. 
Inventory records must be readily available for inspection by regulatory authorities at any time. 
Each shipment of study drug will require acknowledgment of receipt. Upon receipt of study 
drug, the pharmacy or study personnel will visually inspect the shipment and verify the number 
and condition of vials received. Refer to the Pharmacy Manual for additional information. 
8.7. 
Study Drug Handling and Disposal 
Unless expressly disallowed by institution rules or local regulations, used and unused vials 
of CD388 Injection will be retained at the study site until study drug accountability has been 
performed by the Pharmacy Monitor. Upon completion of the study, termination of the study, 
or upon written authorization from the Sponsor, all retained unused and partially used study drug 
will be centrally destroyed or destroyed at the site upon written authorization from Sponsor, 
unless expressly disallowed by local regulations. Adequate documentation to support destruction 
is required prior to destruction of the vials, and a certificate of destruction or written 
documentation that specifies the date, quantity, lot numbers, and method of destruction that is 
traceable to the study drug must be provided to the Sponsor. All records of disposal will be 
maintained by the Sponsor. 


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9. 
STUDY PROCEDURES 
The Schedule of Events (Table 1) summarizes the frequency and timing of all applicable study 
assessments, including allowable windows for study visits and assessments/procedures. Written 
informed consent must be obtained before any study-related procedures are performed. 
All procedures should be completed as close to the prescribed/scheduled time as possible. 
Any nonscheduled procedures required for urgent evaluation of safety concerns take precedence 
over all routine scheduled procedures. 
When multiple assessments are scheduled at the same time point, perform the assessments in the 
following order: 12-lead ECG, vital signs, and blood sample collection.  
9.1. 
Medical History 
A complete medical history will be recorded, including demographic information (age, gender, 
race, and ethnicity).  
9.2. 
Physical Examinations 
A complete physical examination is required at screening. Targeted (i.e., symptom directed) 
physical examinations may be performed at all other indicated visits, and as clinically indicated. 
9.3. 
Vital Signs 
Vital signs include blood pressure (systolic and diastolic), heart rate, respiration rate, and oral 
temperature, and will be measured with the subject in a seated position for at least 3 minutes 
prior to measurement. Height and weight are to be measured and body mass index (BMI) 
calculated when indicated. 
9.4. 
Electrocardiograms 
Subjects should be resting (at least 5 minutes) and semi-recumbent for safety triplicate 12-lead 
ECGs. Data collection includes abnormal findings; if abnormal finding(s) are assessed as 
clinically significant, the finding(s) should be reported as AE(s). The Investigator is responsible 
for interpreting and measuring ECG data. 
The screening ECG may be repeated once to confirm eligibility. 
9.5. 
Laboratory Evaluations 
Blood and urine for laboratory evaluations will be collected and analyzed at a laboratory in 
accordance with quality laboratory standards. Hematology, serum chemistry, coagulation, 
urinalysis, and other parameters to be tested are listed in Table 4. 


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Table 4: 
Clinical Laboratory Tests 
Test Category 
Specific Laboratory Tests 
Hematology: a 
Hemoglobin 
Neutrophils (absolute) 
Hematocrit 
Monocytes (absolute) 
Erythrocyte (red blood count [RBC]) count 
Eosinophils (absolute) 
Quantitative platelet count 
Lymphocytes (absolute) 
Total leukocyte (white blood cell [WBC]) 
count 
Basophils (absolute) 
Mean corpuscular hemoglobin (MCH) 
Mean corpuscular volume (MCV) 
Serum 
Chemistry: a 
Aspartate aminotransferase (AST) 
Calcium 
Alanine aminotransferase (ALT) 
CO2 or bicarbonate 
Alkaline phosphatase (ALP) 
Blood urea nitrogen (BUN) or urea 
Albumin 
Creatinine 
7RWDOELOLUXELQLIWRWDOELOLUXELQLVî
ULN with no evidence of Gilbert’s 
syndrome, then fractionate into direct and 
indirect bilirubin) 
Glucose 
Sodium 
Chloride 
Potassium 
Lipase 
Total protein 
Lactate dehydrogenase (LDH) 
Phosphorus 
Amylase 
Creatinine Clearance (Cockcroft-Gault) 
 
Lipids: b 
Triglycerides 
Low Density Lipoproteins (LDL) 
Cholesterol, Total 
 
Coagulation: b 
Activated partial thromboplastin time 
(aPTT) 
International normalized ratio for prothrombin 
time (INR/PT) 
Complement 
Activation: b 
Complement C3, C4, CH50 
 
Urinalysis: a 
pH 
Occult blood 
Protein 
Specific gravity 
Glucose 
Ketones 
Appearance 
Color 
Bilirubin 
Leukocyte esterase 
Nitrite 
Microscopic reflex if protein, nitrite, blood 
or leukocyte esterase are positive (WBC, 
RBC, epithelial cells, bacteria, casts, other 
findings) 
Serology: 
Hepatitis B surface antigen (HBsAg) c 
Human immunodeficiency virus (HIV) 
antibody c 
Hepatitis C antibody c 
Severe acute respiratory syndrome coronavirus 
2 (SARS-CoV-2) polymerase chain reaction 
(PCR) d 


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Pregnancy: e 
Serum beta human chorionic gonadotropin 
ȕ-hCG) pregnancy test for females of 
childbearing potential (screening and 
Day 120/165 only), urine or serum test at all 
other specified visits 
Follicle-stimulating hormone (FSH), if 
applicable to confirm postmenopausal status, 
is only required once 
Other: f 
Drug (opioids, benzodiazepines, barbiturates, cocaine metabolites, cannabinoids, 
methamphetamines, phencyclidine, amphetamine, cotinine) and alcohol screen 
a. At each visit indicated in the Schedule of Events (Table 1). 
b. Performed at screening, and as clinically indicated (e.g., if the Investigator has concerns regarding an SAE, anti-drug 
antibody reaction in a subject with hypersensitivity reaction, fever, serious rash, joint/bone pain, cough, proteinuria, 
or clinically meaningful changes in the white cell differential or liver function tests). 
c. At screening only. 
d. If a subject develops signs and symptoms of an acute respiratory tract infection at any time during the study, COVID-19, 
influenza, and/or respiratory syncytial virus (RSV), nasopharyngeal rapid antigen test plus PCR will be performed. 
e. As indicated. 
f. At screening and Day -1, and during the outpatient visits if vital signs are abnormal. 
9.6. 
Randomization 
For randomization procedures, see Section 6.6. 
9.7. 
Pharmacokinetics, Pharmacogenomics, Exploratory Biomarkers, 
and Anti-drug Antibodies 
Blood and NP swab samples for pharmacokinetic analysis, pharmacogenomics, exploratory 
biomarkers, and anti-drug antibodies will be collected as indicated in the Schedule of Events 
(Table 1). Refer to the laboratory manual for instructions on collection of these samples for 
analysis. 
Refer to the laboratory manual for instructions on collection of samples from nasopharyngeal 
swab for exploratory CD388 assays.  
9.8. 
Reactogenicity/Injection Site Inspection 
At indicated visits, inspection of administration site and surrounding area will be performed 
twice daily, with any abnormal findings reported as AEs. Reactions will be rated according to 
Table 5. 


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Table 5: 
Injection Site Evaluation 
Local Reaction 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Pain 
Does not interfere 
with activity 
Repeated use of 
non-narcotic pain 
reliever >24 hours or 
interferes with 
activity 
Any use of narcotic 
pain reliever or 
prevents daily activity 
Emergency room (ER) 
visit or hospitalization 
Tenderness 
Mild discomfort to 
touch 
Discomfort with 
movement 
Significant discomfort 
at rest 
ER visit or 
hospitalization 
Erythema/Redness a 
2.5–5 cm 
5.1–10 cm 
>10 cm 
Necrosis or 
exfoliative dermatitis 
Induration/Swelling b 
2.5–5 cm and does 
not interfere with 
activity 
5.1–10 cm or 
interferes with 
activity 
>10 cm or prevents 
daily activity 
Necrosis 
a. In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as 
a continuous variable. 
b. Induration/swelling should be evaluated and graded using the functional scale as well as the actual measurement. 
Source: (FDA 2007). 
9.9. 
Adverse Events  
Information on AEs (event term, start and stop dates, severity, relationship to blinded study drug) 
will be collected from the time of signing the informed consent form (ICF) until the final study 
visit after the dose of study drug. See Section 11 for additional information. 
9.10. 
Prior and Concomitant Medications and Concomitant Procedures 
Prior and concomitant medication usage will be recorded from 28 days prior to CD388 
Injection/placebo administration until the final study visit. See Section 8.5 for permitted 
concomitant medications. 
Concomitant procedures to treat an AE will be recorded from the time of CD388 Injection/
placebo administration until the final study visit. 


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10. 
ASSESSMENT OF EFFICACY 
Not applicable; this study has no efficacy endpoints. 


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11. 
ASSESSMENT OF SAFETY 
11.1. 
Safety Parameters 
Safety and tolerability will be assessed by monitoring AEs (including systemic 
reactogenicity/injection site reactions, hypersensitivity reactions, and AESIs), vital signs, 12-lead 
ECGs, clinical laboratory results (hematology, coagulation, serum chemistry, urinalysis), and 
concomitant medication usage throughout the study. 
11.2. 
Adverse Events 
Adverse events will be collected for all subjects from the time of signing the ICF through the 
final study visit. The Investigator will assess all AEs and SAEs and will record the following 
information on the appropriate eCRF page: 
x Date of onset 
x Resolution status, and date of resolution or stabilization if achieved 
x Seriousness 
x Severity 
x Causal relationship to study drug 
x Action taken with study medication 
Medically indicated laboratory tests (emergency or unscheduled tests) should be conducted 
at the local laboratory. The Investigator should employ best medical judgment in determining 
how to manage AEs and SAEs. Any questions regarding AE or SAE management should be 
directed to the Medical Monitor. 
The Sponsor is responsible for: 
x Confirming the seriousness assessment of all reported AEs and SAEs 
x Confirming the causal relationship between reported AEs/SAEs and the investigational 
product 
x Assessment of SAEs for expectedness 
The Sponsor will continuously assess the safety of the investigational product throughout the 
study. 
11.3. 
Adverse Event Reporting 
11.3.1. 
Notification of Serious Adverse Events 
The Sponsor has requirements for expedited reporting of SAEs meeting specific criteria to 
worldwide regulatory authorities in accordance with ICH guidelines and local regulatory 
requirements. Therefore, the Investigator must notify the Sponsor immediately regarding any 
SAE that occurs after informed consent via transmission of a Serious Adverse Event Report 
(SAER) by the study site to the safety vendor by email within 24 hours of awareness that an SAE 


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has occurred, with a copy to the Medical Monitor. Contact details will be provided to the site(s). 
An optional initial report can be made via telephone, but a completed SAER must still be 
emailed within 24 hours of the site’s knowledge of the event.  
The Investigational site will be provided with SAER forms wherein the following information 
is requested: 
x Subject identification, Investigator name, and site number 
x SAE information: event term, onset date, severity, and causal relationship 
x The outcomes attributable to the event (e.g., death, a life-threatening AE, inpatient 
hospitalization, prolongation of existing hospitalization, a persistent or significant 
disability or incapacity, or other important medical event[s]; refer to Section 11.4.4) 
x A summary of relevant test results, pertinent laboratory data, and any other relevant 
medical history 
x The date of study drug administration (NOTE: as this is a double-blind study, SAERs 
should not indicate specific study drug assignments) 
Supplemental information may be requested, including the following: hospital records, 
laboratory results, radiology reports, progress notes, admission and emergency room notes, 
holding and observation notes, discharge summaries, autopsy reports, and death certificates. 
Relevant eCRF pages can be appended to communicate information relevant to the SAE, 
including study drug administration details, medical history, concomitant medications, relevant 
laboratory test results, and subject outcome information. The SAER should be emailed within 
24 hours with as much of the above information as available at the time. The following minimum 
information is required for reporting an SAE: subject identification, Investigator contact 
information, an AE with a serious outcome, and the Investigator’s assessment of causal 
relationship to study drug. Serious adverse events are to be reported immediately and under no 
circumstance should this reporting time exceed 24 hours following knowledge of the SAE. 
Supplemental information may be transmitted using a follow-up report and should not delay the 
initial report. The Sponsor may contact the investigational site to solicit additional information 
or follow up on the event. 
The Investigator must take all therapeutic measures necessary for resolution of the SAE. 
Any medications or procedures necessary for treatment of the SAE must be recorded on the 
appropriate pages of the subject’s eCRF. 
If the Investigator becomes aware of any SAEs that occur after the study period that are believed 
to be causally related to use of the investigational product, they should notify the Sponsor 
immediately. 
The Sponsor will report all suspected unexpected serious adverse reactions (SUSARs) within the 
required regulatory timeframes to all applicable regulatory authorities and to Investigators as 
required. 
All SAEs that do not meet expedited reporting requirements will be summarized in the 
Development Safety Update Report (DSUR) and reported annually by the Sponsor as required. 


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11.3.2. 
Notification of Emerging Safety Issues 
Additionally, the Investigator should alert the Sponsor immediately (under no circumstance 
should this reporting time exceed 24 hours) by contacting the Medical Monitor of any new 
findings that necessitate the implementation of urgent safety measures to protect subjects against 
any immediate hazard. If time permits, the Investigator should contact the Sponsor to discuss the 
hazard and any actions taken or to be taken prior to implementation.  
The Sponsor is responsible for informing other investigators who may need to implement the 
same procedures and for alerting the Competent Authorities and Ethics Committees of the new 
findings and measures taken in accordance with local regulations within the required timeframes. 
11.4. 
Definitions 
11.4.1. 
Adverse Event 
An AE means any untoward medical occurrence associated with the use of a drug or study 
procedure in humans, whether or not considered drug-related. An AE can be any unfavorable 
and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, 
or disease temporally associated with the use of a drug and does not imply any judgment about 
causality. An AE can arise with any use of the drug (e.g., off-label use, use in combination with 
another drug) and with any route of administration, formulation, or dose, including an overdose. 
Laboratory abnormalities should not be recorded as AEs or SAEs unless they are associated with 
clinical signs or symptoms, or require medical intervention. However, each laboratory 
abnormality (e.g., clinically significant changes detected on hematology, coagulation, chemistry, 
urinalysis) independent from any underlying medical condition that requires medical or surgical 
intervention, or that leads to interruption of study drug or discontinuation, must be recorded 
as an AE, or SAE if applicable. If the laboratory abnormality is part of a clinical condition 
or syndrome, it should be recorded as the syndrome or diagnosis rather than as the individual 
laboratory abnormality. In addition, laboratory abnormalities or other abnormal test assessments 
(e.g., ECGs) that are associated with signs or symptoms must be recorded as AEs or SAEs if they 
meet the definition of an AE or SAE as described in this section and in Section 11.4.4, 
respectively. 
11.4.2. 
Suspected Adverse Reaction 
A suspected adverse reaction is any AE for which there is a reasonable possibility that the drug 
caused the AE. For the purposes of Investigational New Drug (IND) safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal relationship between the 
drug and the AE. “Suspected adverse reaction” implies a lesser degree of certainty about 
causality than “adverse reaction”, which means any AE caused by a drug.  
11.4.3. 
Life-Threatening AE or Life-Threatening Suspected Adverse Reaction 
An AE or suspected adverse reaction is considered “life threatening” if, in the view of either 
the Investigator or Sponsor, its occurrence places the subject at immediate risk of death. It does 
not include an AE or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 


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11.4.4. 
Serious Adverse Event or Serious Suspected Adverse Reaction 
An AE or suspected adverse reaction is considered “serious” if, in the view of either 
the Investigator or Sponsor, it results in any of the following outcomes: 
x Death 
x A life-threatening AE – see definition above 
x Inpatient hospitalization or prolongation of existing hospitalization 
x A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
x A congenital anomaly/birth defect in the offspring of a subject who received study drug 
x Is a suspected transmission of any infectious agent via a medicinal product 
x Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition 
11.4.5. 
Unexpected AE or Unexpected Suspected Adverse Reaction 
An AE or suspected adverse reaction is considered “unexpected”: 
x If it is not listed in the Investigator’s Brochure or is not listed at the nature, severity, 
frequency, or outcome that has been observed 
For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater 
severity) if the Investigator’s Brochure referred only to elevated hepatic enzymes or hepatitis. 
Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of 
greater specificity) if the Investigator’s Brochure listed only cerebral vascular accidents. 
“Unexpected”, as used in this definition, also refers to AEs or suspected adverse reactions that 
are mentioned in the Investigator’s Brochure as occurring with a class of drugs or as anticipated 
from the pharmacological properties of the drug but are not specifically mentioned as occurring 
with the particular drug under investigation. 
11.4.6. 
Adverse Events of Special Interest 
Adverse events of special interest (AESIs) include anaphylaxis (refer to Appendix 3 for 
diagnostic criteria and management). 
11.4.7. 
Emerging Safety Issue 
Any new safety information that may lead to a reassessment of the risk/benefit balance of the 
investigational product and/or impact subjects’ health. Examples include: 
x Any new safety issue relating to the conduct of the clinical trial that may impact the 
safety of the trial subjects such as significant safety results from a recently completed 
non-clinical study or early termination or temporary suspension of a trial for safety 
reasons that is conducted on the same investigational product 


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x Recommendations from a Data Review Committee that may affect the safety of trial 
subjects  
11.4.8. 
Urgent Safety Measure 
An urgent safety measure (USM) is a procedure not defined by the protocol that can be put in 
place immediately, without prior authorization from Ethics Committees or Regulatory 
Authorities, to protect study subjects from any immediate hazard to their health and safety. 
11.5. 
Adverse Event Classification 
11.5.1. 
Relationship to Study Drug 
The Investigator’s assessment of causality must be provided for all AEs (serious and nonserious; 
Table 6). An Investigator’s causality assessment is the determination of whether there exists 
a reasonable possibility that the study drug caused or contributed to an AE. 
These criteria, in addition to good clinical judgment, should be used as a guide for determining 
the causal assessment. If the event is thought to be unrelated to study drug administration, 
an alternative explanation should be provided. 
Table 6: 
Table Guidelines for Assessing Relationship of Event to Study Drug 
Unrelated 
There is little or no chance that the study drug caused the adverse event (AE); other conditions, 
including concurrent illnesses, progression or expression of the disease state, or a reaction 
to a concomitant medication best explain the event. 
Related 
The association of the AE with the study drug is unknown; however, the AE is not clearly due to 
another condition, or a reasonable temporal association exists between the AE and study drug 
administration and, based on the Investigator's clinical experience, the association of the AE 
with the study drug seems likely. 
11.5.2. 
Severity 
For injection site reactions, the Investigator will use the grading scale in Table 5. To describe the 
intensity of all other AEs following general categorical descriptors outlined in the DAIDS table 
for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS 2017), the grading scale 
in Table 7 will be used. 
Table 7: 
Guidelines for Severity Assessments 
Grade 1 
Mild 
Mild symptoms causing no or minimal interference with usual social and functional activities 
with intervention not indicated 
Grade 2 
Moderate 
Moderate symptoms causing greater than minimal interference with usual social and 
functional activities with intervention indicated 
Grade 3 
Severe 
Severe symptoms causing inability to perform usual social and functional activities with 
intervention or hospitalization indicated 
Grade 4 
Potentially Life 
Threatening 
Potentially life-threatening symptoms causing inability to perform basic self-care functions 
with intervention indicated to prevent permanent impairment, persistent disability, or death 
Grade 5 
Death 
Fatal 
Refer to the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events for details regarding event grading. 


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11.5.3. 
Serious Adverse Event 
Any adverse experience occurring at any dose of study medication that occurs from the time 
of informed consent through the final study visit, are considered serious if they result in any of 
the outcomes listed in Section 11.4.4. 
Hospitalization for a planned or elective procedure or surgery for a pre-existing condition that 
has not worsened is not considered an SAE. 
11.6. 
Adverse Event Follow Up 
All unresolved SAEs and study drug-related AEs will be followed by the study staff until 
resolution or deemed stable, regardless of severity. 
11.7. 
Adverse Event Management 
The Investigator should employ best medical judgement in determining how to manage AEs. 
Any questions regarding AE management should be directed to the Medical Monitor. 
11.8. 
Risks for Women of Childbearing Potential or During Pregnancy 
The risks of CD388 Injection in pregnant or lactating/nursing women are unknown. Pregnant 
or nursing female subjects are excluded from this study. 
Subjects must be instructed to inform the Investigator immediately if they or their partner 
becomes pregnant during the study. In the case of a partner pregnancy, partner informed 
consent must be obtained prior to collecting information related to the pregnancy and to allow 
the Investigator to follow them for the outcome of the pregnancy. In the event of a confirmed 
pregnancy, the following actions should be taken: 
x The pregnancy should be reported to the Sponsor within 24 hours of the subject notifying 
the Investigator using the applicable Pregnancy Report Form. 
x The Investigator should counsel female subjects regarding the possible effects of CD388 
Injection exposure on the fetus and the need to inform the study site of the outcome of the 
pregnancy. 
x The subject or subject’s partner, if consented, should be monitored until the postnatal 
day 28 or until termination of the pregnancy. The outcome should be reported using 
the Pregnancy Outcome or Abnormal Pregnancy Outcome form. 
Pregnancy is not an AE, in and of itself. However, any pregnancy complication or elective 
termination of a pregnancy for medical reasons will be recorded as an AE or SAE. 
A spontaneous abortion is always considered an SAE and will be reported as described in the AE 
and SAE sections. Furthermore, any SAE occurring as an adverse pregnancy outcome post-study 
must be reported to the Medical Monitor. 


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12. 
STATISTICAL METHODS 
A Statistical Analysis Plan (SAP) will be prepared and finalized before unblinding for the first 
interim analysis. Any deviations from the final SAP will be described and justified in the study 
report. All statistical analyses will be performed using SAS®. 
Descriptive statistics, including the numbers and percentages for categorical variables, and the 
numbers, means, standard deviations, medians, minimums, and maximums for continuous 
variables, will be provided. All data will be summarized separately by dose level and study drug 
(CD388 Injection or placebo). Listings of individual subject data will also be produced. 
Safety, tolerability, and PK will be summarized using descriptive statistics. There will be no 
formal hypothesis testing.  
12.1. 
Analysis Populations 
Analysis populations are: 
x Safety Population: all subjects who receive any amount of study drug 
x PK Analysis Population: all subjects who receive CD388 Injection and who have any 
blood samples analyzed 
12.2. 
Analysis of Study Population and Subject Characteristics 
Demographics (including age, race, ethnicity, and gender), baseline assessments (including 
height, weight, and BMI), medical history, and administration of study drug will be summarized 
for the Safety Population. 
12.3. 
Safety Analyses 
Safety will be evaluated by presenting summaries of AEs and SAEs, ECGs, clinical laboratory 
evaluations (hematology, coagulation, serum chemistry, urinalysis), and vital signs. Adverse 
events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). 
The incidence of TEAEs and AESIs will be presented by System Organ Class (SOC) 
and Preferred Term (PT), relationship to study drug, and severity. A TEAE is defined as an AE 
that emerges during or after study drug administration having been absent pre-treatment, or 
worsens relative to the pre-treatment state, and through the final study visit. In addition, the 
incidence of serious TEAEs and TEAEs leading to discontinuation of study drug or from the 
study will be presented by SOC and PT.  
Descriptive statistics for clinical laboratory test results, ECG parameters, and vital signs, and for 
changes from Baseline, will be presented by time point. The incidences of potentially clinically 
significant (PCS) clinical laboratory results, ECG parameters, and vital signs will also be 
summarized by time point.  
A summary of the injection site evaluation will be presented. The number and percentage of 
subjects with any local reaction will be provided, as will the number and percentage of subjects 
with pain, tenderness, erythema/redness, and induration/swelling. The severity of each local 
reaction will also be presented. 


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12.4. 
Pharmacokinetic Analyses 
Based on the individual plasma concentration-time data, using the actual sampling times 
(see Schedule of Events, Table 1), the following PK parameters will be included: 
x maximum plasma concentration (Cmax) 
x time to maximum plasma concentration (Tmax) 
x terminal elimination half-life (t½) 
x apparent clearance (CL/F) 
x apparent volume of distribution (VZ/F)  
x area under the plasma concentration-time curve from time 0 to time of last quantifiable 
sample (AUC0-last) 
x area under the plasma concentration-time curve from time 0 extrapolated to infinity 
(AUC0-) 
CD388 concentration in the upper respiratory tract will also be determined. 
Pharmacokinetic parameter estimation will be performed by non-compartmental analysis (NCA) 
with Phoenix® WinNonlin® version 8 or higher. The actual elapsed sampling times relative to 
dosing will be recorded during the study and will be used in the NCA analysis. Pharmacokinetic 
data handling and analysis will be further detailed in the SAP. 
Descriptive statistics will be calculated for plasma concentrations at each individual time point 
and for all PK parameters. Mean and individual plasma concentration-time profiles will be 
presented graphically. Inferential statistics will also be conducted for log transformed PK 
exposure parameters versus historical control data in Western subjects from Study 
CD388.IM.SQ.1.01. 
Pharmacokinetic samples for CD388 from this study may also be included in a population PK 
analysis, which will be reported separately. 
12.5. 
Analyses of Pharmacogenomics, Exploratory Biomarkers, 
and Anti-Drug Antibodies 
Analysis of the ADA results is to be determined and may include determination of the subject’s 
positive/negative ADA status at baseline, treatment-emergent ADA in subjects with a negative 
baseline, as well as a post-baseline increase in titer for subjects with positive ADA at baseline. 
Pharmacogenomics, and exploratory biomarkers will be reported separately. 
12.6. 
Analyses of Respiratory Tract Infections 
The number and percentage of subjects with any RTI will be provided. 
12.7. 
Interim Analysis 
After 50% of Cohort 1 subjects have completed study drug administration and have undergone 
protocol-specified procedures and DVVHVVPHQWVIRU days, the Principal Investigator (PI) 


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and Sponsor will review blinded safety data: AEs (including systemic reactogenicity/injection 
site reactions, hypersensitivity reactions, and AESIs), vital signs, 12-lead ECGs, and clinical 
laboratory results (hematology, coagulation, serum chemistry, urinalysis) to determine the safety 
and tolerability of the study drug. The incidence and severity of AEs, and any adverse changes in 
vital signs, clinical laboratory findings, and ECGs will be considered when determining safety 
and tolerability of study drug. If the GRVHLVGHWHUPLQHGWREHVDIHDQGZHOOWROHUDWHGGD\V
after dosing, Cohort 2 will be enrolled. Enrollment of the remaining 50% of Cohort 1 will 
continue while the safety data of the first 50% of Cohort 1 is being reviewed. Similar processes 
will be followed for dose escalation from Cohort 2 to Cohort 3. 
After the final subject of Cohort 2 has completed the Day 90 visit, Cohorts 1 and 2 may be 
unblinded for a formal interim data analysis. In addition, unblinded data reviews may occur as 
needed. 
12.8. 
Determination of Study Sample Size 
A total of 27 subjects will be enrolled in this study, with 21 of these subjects to receive CD388 
Injection and 6 to receive placebo. The number of subjects was selected to allow sufficient 
evaluation of safety and tolerability, and PK, and is consistent with standards of practice for 
Phase 1 ethnic bridging studies. 
12.9. 
Handling of Dropouts and Missing, Unused, and Spurious Data 
Every effort will be made to collect all data at specified times. Handling of missing data will be 
detailed in the SAP. 
12.10. 
Subject Disposition 
Enrollment and discontinuations from the study will be summarized, including the reasons for 
discontinuation. 
12.11. 
Deviation Reporting 
Protocol deviations will be summarized. Protocol deviations are defined as any variation from 
the protocol, including enrollment of a subject who did not meet all inclusion and exclusion 
criteria and failure to perform the assessments and procedures within the required time frame. 


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13. 
INVESTIGATOR REQUIREMENTS 
13.1. 
Protocol Adherence 
The Investigator must adhere to the protocol as detailed in this document and agree that the 
Sponsor must approve any change to the protocol before seeking approval from the IRB/IEC. 
The Investigator will be responsible for enrolling only those subjects who have met the study 
selection criteria. 
13.2. 
Electronic Case Report Forms 
The contract research organization will make the eCRF accessible to authorized personnel 
over the internet from an electronic data capture (EDC) system used for the recording of study 
data as specified by this protocol. All eCRFs must be completed by trained study personnel. 
The Investigator is responsible for ensuring that the eCRF data are entered and completed 
in a timely manner. 
Once all data queries and issues have been resolved for each subject, the Investigator will 
electronically sign each subject’s eCRF to attest to the accuracy of the data. 
13.3. 
Source Document Maintenance 
Source documents are defined as documentation related to original observations and activities 
of a clinical investigation. Source documents may include, but are not limited to, study progress 
notes, study- or subject-specific e-mail correspondence, computer printouts, laboratory data, 
and recorded data from automated instruments. All source documents produced in this study will 
be maintained by the Investigator and made available for inspections by the Sponsor and by 
regulatory authorities. The original signed ICF for each participating subject shall be filed with 
records kept by the Investigator, and a copy shall be given to the subject. 
13.4. 
Study Monitoring Requirements 
An authorized Sponsor representative will conduct site visits to inspect study data, subjects’ 
medical records, and eCRFs in accordance with ICH guidelines, GCP, and the foreign 
regulations and guidelines, as applicable. A monitor will be utilized for monitoring ongoing drug 
accountability and adherence to protocol procedures. 
The Investigator will allow representatives of the Sponsor and regulatory authorities to inspect 
facilities and records relevant to this study. 
13.5. 
Study Completion 
The Sponsor requires the following data and materials before a study can be considered complete 
or terminated: 
x Laboratory findings, clinical data, and all special test results from screening throughout 
the study  
x eCRFs (including data queries) properly completed by appropriate study personnel, 
signed and dated by the Investigator 


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x Copies of complete drug accountability records (drug inventory log and an inventory 
of returned or destroyed clinical material) 
x Copies of protocol amendments and IRB/IEC approval and notification, if appropriate 
x A summary of the study prepared by the Investigator (an IRB/IEC summary letter 
is acceptable) 
End of Study Conduct, for the purpose of clinical trial registries, end of trial notifications to 
regulatory authorities and IRBs/ECs, will be the latest date on which the last visit in time of any 
study subject occurs. 


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14. 
QUALITY CONTROL AND QUALITY ASSURANCE  
Written Standard Operating Procedures (SOPs) will be followed to ensure that the study is 
conducted, and data are generated, documented (recorded), and reported in compliance with the 
protocol, GCP, and the applicable regulatory requirements. Quality control will be applied to 
each stage of data handling. Regular monitoring, as defined in ICH GCP E6(R2), Section 1.38, 
“The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, 
recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable 
regulatory requirement(s)”, will be conducted throughout the conduct of the study. 
As defined in ICH GCP E6(R2), Section 5.18.1, the purpose of monitoring is to verify that: 
x Rights and well-being of the human subjects are protected. 
x The reported study data are accurate, complete, and verifiable from source documents. 
x The conduct of the study is compliant with the currently approved 
protocol/amendment(s), with GCP, and with the applicable regulatory requirements. 
x Monitoring is an integral role in the quality control of a clinical trial and is designed to 
verify the quality of the study. 
To fulfill the Quality Assurance requirements of GCP, audits will be conducted to assess 
and assure the reliability and integrity of a study’s quality control systems and recognized 
standards. 
As defined in ICH GCP E6(R2), Section 5.19, the purposes of an audit are to: 
x Ensure subject safety 
x Assure compliance to study protocol procedures, regulatory requirements, and SOPs 
x Assure data quality 


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15. 
PROTECTION OF HUMAN SUBJECTS 
This study will be conducted in compliance with the ICH Technical Requirements for 
Registration of Pharmaceuticals for Human Use E6(R2) Guideline for Good Clinical Practice, 
the ethical principles of the Declaration of Helsinki, FDA GCP guidelines, and any additional 
national or IRB/IEC-required procedures. 
15.1. 
Informed Consent 
This study will be conducted in compliance with ICH E6(R2) Guideline for Good Clinical 
Practice pertaining to informed consent. Subjects will give written consent to participate in the 
study at the first visit, prior to initiation of any study-related procedures, after having been 
informed about the nature and purpose of the study, participation and termination conditions, 
risks, and benefits. If a subject is unable to provide written informed consent, the subject’s 
legally acceptable representative (i.e., acceptable to ICH and local law, as applicable) may 
provide written consent, as approved according to institution-specific guidelines. The ICF must 
be signed and dated by the subject, or the subject’s legally acceptable representative, prior to 
study participation. A copy of the ICF must be provided to the subject or the subject’s legally 
acceptable representative. If applicable, it will be provided in certified translation for 
non-English-speaking subjects. Signed ICFs must remain in the subject’s study file and be 
available for verification by Sponsor at any time. 
15.2. 
IRB/IEC Approval 
This protocol, the ICF, and all relevant supporting data must be submitted to the IRB/IEC 
for approval. The protocol, ICF, and any advertisement used to recruit study subjects must 
be approved by the IRB/IEC. Approval by the IRB/IEC of the protocol and ICF must be obtained 
before the study may be initiated. 
The Investigator is responsible for informing the IRB/IEC of any changes made to the protocol, 
and to advise them, at least once a year, about the progress of the study. The Investigator is also 
responsible for notifying the IRB/IEC of any significant AEs that occur during the study. 


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16. 
DATA HANDLING AND RECORD KEEPING 
Training sessions, regular monitoring of Investigators by Sponsor-designated personnel, 
instruction manuals, data verification, crosschecking, and data audits will be performed to ensure 
quality of all study data. Investigator meetings may be performed to prepare Investigators 
and other study personnel for appropriate collection of study data. 
The Sponsor will review and validate study data as defined in the monitoring plan. 
It will be the responsibility of the Investigator to ensure that the essential documents 
are available at the study site. Any or all these documents may be subject to, and should be 
available for, monitoring by the Sponsor or inspection by the regulatory authorities as defined 
in the monitoring plan. 
16.1. 
Direct Access to Source Data/Documentation 
The Investigator agrees by his/her participation that the results of this study may be used for 
submission to national or international registration. If required, these authorities will be provided 
with the name of the Investigator and his or her address, qualifications, and extent of 
involvement. It is understood that the Investigator is required to provide Sponsor with all study 
data, complete reports, and access to all study records. 
Data generated by this study must be available for inspection by any regulatory authorities, 
by the Sponsor and by the IRB/IEC as appropriate. At a subject’s request, medical information 
may be given to his or her personal physician or other appropriate medical personnel responsible 
for his or her welfare. Medical information obtained from subjects during the course of this study 
is confidential and disclosure to third parties other than those noted above is prohibited. 
16.2. 
Study Drug Accountability 
All supplies of CD388 Injection/placebo required for completion of this study will be provided 
by the Sponsor. It is the responsibility of the unblinded Pharmacy or study staff to ensure that 
a current record of drug inventory and drug accountability is maintained. Inventory and 
accountability records must be readily available for inspection by the monitor and are open to 
inspection at any time by applicable regulatory authorities. 
16.3. 
Retention of Records 
Essential documents should be retained until at least 2 years after the last approval of 
a marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product and shipment and delivery 
of the drug for investigational use is discontinued. These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirements of specific 
ICH and non-ICH countries, or by an agreement with the Sponsor. The Sponsor will inform 
the Investigator/institution as to when these documents no longer need to be retained. 


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16.4. 
Long-term Retention of Samples for Additional Future Research 
Samples collected in this study may be stored for up to 15 years (or according to local 
regulations) for additional research. Samples will only be used for research related to influenza 
virus infection, flu-like disease, and safety, reactogenicity, and immunogenicity of CD388. They 
may also be used to develop tests/assays related to CD388 and influenza. The research may 
begin at any time during the study or the post-study storage period. 
Stored samples will be coded throughout the sample storage and analysis process and will not be 
labeled with personal identifiers. Subjects may withdraw their consent for their samples to be 
stored for research.  


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17. 
FINANCING AND INSURANCE 
The financing and insurance for this study are outlined in the Clinical Trial Agreement. 


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18. 
PUBLICATION POLICY 
The data generated in this clinical study are the exclusive property of the Sponsor and are 
confidential. Authorship on any publication of the results from this study will be based 
on contributions to study design, enrollment, data analysis, and interpretation of results. 


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19. 
REFERENCES 
Abbasi J. The search for a universal flu vaccine heats up. JAMA. 2019; 322(20): 1942–1944. 
Brammer L. Influenza Surveillance Update. Presented to ACIP June 27, 2019. Available at: 
https://stacks.cdc.gov/view/cdc/80753. Accessed 20 July 2022. 
FDA Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical 
Trials for Therapeutics in Adult Healthy Volunteers. July 2005. Available at: 
https://www.fda.gov/media/72309/download. Accessed 20 July 2022. 
FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials. September 2007. Available at: 
https://www.fda.gov/media/73679/download. Accessed 20 July 2022. 
Flannery B, Chung J, Ferdinands J, Smith E, Campbell A, Ogokeh C. Preliminary estimates of 
the 2018-2019 seasonal influenza vaccine effectiveness against medically attended influenza 
from three U.S. networks. Presented to ACIP June 27, 2019. Available at: 
https://stacks.cdc.gov/view/cdc/80754. Accessed 20 July 2022. 
Iuliano AD, Roguski KM, Chang HH, Muscatello DJ, Palekar R, Tempia S, et al. Global 
Seasonal Influenza-associated Mortality Collaborator Network. Estimates of global seasonal 
influenza-associated respiratory mortality: a modelling study. Lancet. 2018; 391(10127): 
1285– 1300. 
National Institute of Allergy and Infectious Diseases. Division of AIDS (DAIDS) Table for 
Grading the Severity of Adult and Pediatric Adverse Events, corrected v2.1. July 2017. 
Available at: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. Accessed 
20 July 2022. 
Okoli GN, Otete HE, Beck CR, Nguyen-Van-Tam JS. Use of neuraminidase inhibitors for rapid 
comtainment of influenza: a systematic review and meta-analysis of individual and household 
transmission studies. PLoS One. 2014; 9(12): e113633. 
Paules C, Subbarao K. Influenza. Lancet. 2017; 390(10095): 697–708. 
Sampson HA, Munoz-Furlong, Campbell RL, Thomas S, Wood JP, Decker WW. Second 
symposium on the definition and management of anaphylaxis: Summary report—Second 
National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network 
symposium. J Allergy Clin Immun. 2006; 117(2): 391–397. 


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20. 
APPENDICES 
 


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APPENDIX 1. ACCEPTABLE METHODS OF CONTRACEPTION 
An acceptable method of contraception includes one of the following: 
x Abstinence from heterosexual intercourse 
x Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth 
control products, transdermal patch) 
x Intrauterine device (with or without hormones) 
x A double barrier method (e.g., condom and spermicide) 
 


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APPENDIX 2. ECG AND VITAL SIGN ABNORMALITIES 
 
Important abnormalities from the ECG readings are summarized below:  
Abnormality 
ECG Parameter 
HR 
PR 
QRS 
QTcF 
Abnormalities on actual values 
Abnormally low 
<45 bpm 
NA 
- 
- 
Abnormally high 
ESP 
>220 msec 
PVHF 
- 
Borderline prolonged QT (males) 
- 
- 
- 
450 msec to PVHF 
Borderline prolonged QT (females) 
  
  
  
470 msec to PVHF 
Prolonged QT 
- 
- 
- 
481 msec to 500 msec 
Pathologically prolonged QT 
- 
- 
- 
>500 msec 
Abnormalities on changes from baseline 
Normal QTcF change 
- 
- 
- 
<30 msec 
Borderline QTcF change 
- 
- 
- 
30 msec WR60 msec 
Abnormally high QTcF change 
- 
- 
- 
>60 msec 
Abbreviations: bpm = beats per minute; HR = heart rate; NA = not applicable; PR = PR interval; QRS = QRS interval; 
QTcF = QT interval corrected for heart rate using Fridericia’s formula. 
 
Important abnormalities for vital signs are summarized below: 
Abnormality 
Vital Signs Parameter 
HR 
DBP 
SBP 
Abnormally low 
ESP 
PP+J 
PP+J 
Grade 1 or mild 
- 
>90 mmHg to <100 mmHg 
>140 mmHg to <160 mmHg 
Grade 2 or moderate 
- 
PP+JWRPP+J 
PP+JWRPP+J 
Grade 3 or severe 
- 
PP+J 
PP+J 
Abnormally high 
ESP 
- 
- 
Abbreviations: DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure. 
  
 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Fever a 
38.0 to <38.6°C 
(100.4 to <101.5°F) 
WR& 
(WR)) 
WR& 
WR) 
& 
) 
a. Non-axillary temperatures only. 
 
For tachypnea and hypoxia, refer to the grading scale in Table 7. 


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APPENDIX 3. DIAGNOSTIC CRITERIA AND MANAGEMENT FOR 
ANAPHYLAXIS 
Diagnostic Criteria for Anaphylaxis 
Anaphylaxis is highly likely when any one of the following 3 criteria are fulfilled: 
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, 
mucosal tissue, or both (e.g., generalized hives, pruritus or flushing, swollen 
lips, -tongue, -uvula) 
and at least one of the following: 
a. Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia) 
b. Reduced blood pressure or associated symptoms of end-organ dysfunction 
(e.g., hypotonia [collapse], syncope, incontinence) 
2. Two or more of the following that occur rapidly after exposure to a likely allergen for 
that subject (minutes to several hours): 
a. Involvement of the skin-mucosal tissue (e.g., generalized hives, itch-flush, swollen 
lips-tongue-uvula) 
b. Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia) 
c. Reduced blood pressure or associated symptoms (e.g., hypotonia [collapse], syncope, 
incontinence) 
d. Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting) 
3. Reduced blood pressure after exposure to known allergen for that subject (minutes to 
several hours): 
a. Systolic blood pressure <90 mmHg or >30% decrease from that person's baseline 
 
Management of Anaphylaxis 
1. Epinephrine: When a subject meets any of the diagnostic criteria, the subject should 
receive epinephrine immediately, as it is the treatment of choice in anaphylaxis. Aqueous 
epinephrine, 0.01 mg/kg (maximum dose, 0.5 mg) administered intramuscularly every 
5 to 15 minutes as necessary, is the recommended dosage for controlling symptoms 
and maintaining blood pressure. The 5-minute interval between injections can be 
liberalized to permit more frequent injections if deemed necessary by the clinician. 
2. Oxygen and adrenergic agonists: High-flow oxygen (through a nonrebreather mask 
or endotracheal tube) should be administered to subjects experiencing respiratory 
symptoms or hypoxemia. Those who are hemodynamically unstable might benefit from 
R[\JHQDVZHOO,QKDOHGȕ2-agonists, such as albuterol, might be useful for bronchospasm 
refractory to epinephrine. 


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3. Positioning of the subject: Subjects in anaphylactic shock (i.e., those with anaphylaxis 
and signs of critical organ hypoperfusion) should be placed in a recumbent position with 
the lower extremities elevated unless precluded by shortness of breath or vomiting. 
4. Fluid resuscitation: Subjects who remain hypotensive despite epinephrine should have 
aggressive fluid resuscitation. Large volumes of crystalloid might be needed in the first 
5 to 10 minutes; in severe reactions with hypotension, up to 35% of the blood volume 
might extravasate in the first 10 minutes, and vasodilatation can cause pooling, with even 
more reduction in the effective blood volume and thus distributive shock. 
5. Vasopressors: Potent vasopressors, such as noradrenaline, vasopressin, or metaraminol, 
might be required to overcome vasodilatation if epinephrine and fluid resuscitation have 
failed to maintain a systolic blood pressure of greater than 90 mmHg. 
6. H1- and H2-antihistamines: Antihistamines (H1- and H2-antagonists) are slower in onset 
of action than epinephrine, have little effect on blood pressure, and should be considered 
a second-line treatment for anaphylaxis. 
7. Corticosteroids: Because the onset of action is slow, steroids are not useful in the acute 
management stage. It has been suggested that their use might prevent a protracted or 
biphasic reaction. 
8. *OXFDJRQIRUSHUVLVWHQWK\SRWHQVLRQLQVXEMHFWVWDNLQJȕ-blocker: Theoretically, there 
DUHPXOWLSOHPHFKDQLVPVE\ZKLFKȕ-blockade could blunt the response to epinephrine. 
If administration of epinephrine in these subjects is ineffective, administration of 
glucagon can be attempted. Glucagon is thought to reverse refractory hypotension 
and EURQFKRVSDVPE\DFWLYDWLQJDGHQ\ODWHF\FODVHLQGHSHQGHQWRIWKHȕ-receptor; 
however, the occurrence and importance of this mechanism of action in anaphylaxis is 
unproved. 
9. Observation: After the treatment of an anaphylactic reaction, an observation period 
should be considered for all subjects as the reaction might recur as the effect of 
epinephrine wears off (intramuscular epinephrine results in increased serum levels for 
an hour or more) and because of the risk of a biphasic reaction (1–72 hours after the acute 
reaction).  
 
Source: Sampson 2006.


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APPENDIX 4. RASH MANAGEMENT 
For subjects reporting rash, the following should be performed: 
All rashes will be discussed between the Investigator and the Sponsor, and in case of a causal 
relationship between the rash and the study drug, then the following visits and assessments 
will be performed as indicated below and in the “Visit Schedule for Rash Management” 
(see Appendix 5). Unscheduled follow-up visits for close follow-up of rash will be performed 
based on the grade (severity) of the rash. At the Investigator’s discretion, additional visits 
and assessments may be performed. 
The rash event should be captured in the AE section of the electronic case report form (eCRF), as 
well as in more detail in the specific rash assessment pages of the eCRF. 
In case of rash, blood samples need to be collected for safety laboratory testing, and processed by 
the local laboratory. These samples need to be collected during the unscheduled visits as 
described below and in Appendix 5. A copy of the local laboratory reports should be anonymized 
and will be retrieved by the monitor. 
The following parameters need to be tested: aspartate aminotransferase (AST), alanine 
aminotransferase (ALT), creatinine, erythrocyte sedimentation rate, and a complete blood cell 
count (including hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] 
count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet count). 
Digital pictures need to be taken as described below and in Appendix 5. Digital pictures will be 
anonymized and stored on the Sponsor’s secure server. Only the study team will have access to 
the pictures. 
The subject may be treated symptomatically until the rash resolves. If the rash is considered to be 
most likely due to concomitant illness or non-study medication, standard management, including 
discontinuation of the likely causative agent, should be undertaken, and the continuation of the 
subject in the study should be discussed with the Sponsor. 
Dermatologist fees for evaluating subjects who experience a rash will be reimbursed by the 
Sponsor. 
The following grades are based on the DAIDS Toxicity Grading Scale (DAIDS 2017) with 
adaptations made by the Sponsor: 
Subjects should be informed that they should contact their doctor and visit the clinic 
immediately (unscheduled visit, day 1 of the rash) when they notice any rash. 
Grade 1 Rash 
A Grade 1 rash is defined as erythema. 
x Subjects may continue the intake of study drug(s) (at the Investigator’s discretion). 
x An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
x Assessment of safety blood samples by the local laboratory is required. A copy of the 
local laboratory report should be anonymized and will be retrieved by the monitor. 


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Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 68 of 74 
x Digital pictures should be taken within 24 hours after the onset of the rash. 
x Referral to a dermatologist is only needed if the rash diagnosis is uncertain (preferably 
within 24 hours after the onset of the rash). A copy of the dermatologist’s report should 
be anonymized and will be retrieved by the monitor. 
x Cetirizine, levocetirizine, topical corticosteroids, or antipruritic agents may be prescribed. 
x The description of the rash should be reported per ‘Unscheduled Visit in Case of Rash’ in 
the eCRF (i.e., the initial rash assessment pages). 
For close follow-up of the rash, unscheduled visits will also be performed 1 and 7 days after the 
initial assessment of the rash. At these visits, safety blood samples and digital pictures should be 
taken. The follow-up rash assessment pages of the eCRF should be completed for all follow-up 
visits. For these and all subsequent local laboratory blood sample assessments: a copy of the 
local laboratory reports should be anonymized and will be retrieved by the monitor. 
If the rash is unresolved after 7 days, additional unscheduled visits may be performed at the 
Investigator’s discretion. Upon resolution/stabilization of the rash, digital pictures should be 
taken and the final rash assessment pages of the eCRF should be completed. 
The subject should be advised to contact the Investigator immediately if there is any 
worsening of the rash, if any systemic signs or symptoms appear, or if mucosal involvement 
develops. 
In case the rash evolves from a Grade 1 to a higher grade, additional unscheduled visits have to 
be conducted according to the guidelines for Grade 2 or Grade 3–4 rash, respectively. 
Grade 2 Rash 
A Grade 2 rash is defined as diffuse, maculopapular rash OR dry desquamation. 
x Subjects will permanently discontinue the intake of study drugs and be withdrawn from 
the study. No rechallenge is allowed. 
Note: Subjects experiencing Grade 2 rash following the last intake of study drug may 
continue in the study as long as they are not re-exposed to suspect study drug. 
x An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
x Assessment of safety blood samples by the local laboratory is required. A copy of the 
local laboratory report should be anonymized and will be retrieved by the monitor. 
x Digital pictures should be taken within 24 hours after the onset of the rash. 
x Referral to a dermatologist is required, preferably within 24 hours after the onset of the 
rash. A copy of the dermatologist’s report should be anonymized and will be retrieved by 
the monitor. 
x A biopsy is performed (preferably within 24 hours after the onset of the rash) if advised 
by the dermatologist. A copy of the biopsy report should be anonymized and will be 
retrieved by the monitor. 
x Cetirizine, levocetirizine, topical corticosteroids, or antipruritic agents may be prescribed. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 69 of 74 
x The description of the rash should be reported per ‘Unscheduled Visit in Case of Rash’ in 
the eCRF (i.e., the initial rash assessment pages). 
For close follow-up of the rash, unscheduled visits will also be performed 1 and 7 days after the 
initial assessment of the rash. At these visits, safety blood samples and digital pictures should be 
taken. The follow-up rash assessment pages of the eCRF should be completed for all follow-up 
visits. For these and all subsequent local laboratory blood sample assessments: a copy of the 
local laboratory reports should be anonymized and will be retrieved by the monitor. 
If the rash is unresolved after 7 days: 
x And there is an increase in AST/ALT of 1 or 2 times the baseline value OR an increase in 
AST/ALT of less than 5 times the upper limit of normal (ULN), subjects should be 
followed weekly with repeated local lab assessments and digital pictures until resolution 
of the AST/ALT abnormalities. 
x And there is no increase in AST/ALT, additional unscheduled visits (including local lab 
assessments and digital pictures) may be performed at the Investigator’s discretion. 
Upon resolution/stabilization of the rash, digital pictures should be taken and the final rash 
assessment pages of the eCRF should be completed. 
The subject should be advised to contact the Investigator immediately if the rash fails to 
resolve (after more than 2 weeks), if there is any worsening of the rash, if any systemic 
signs or allergic symptoms develop, or if mucosal involvement develops. 
In case the rash evolves from a Grade 2 to a Grade 3–4 rash, additional unscheduled visits must 
be conducted according to the guidelines for Grade 3–4 rash. 
Grade 3 or Grade 4 Rash 
A Grade 3 rash is defined as: 
x vesiculation, moist desquamation, or ulceration OR 
x cutaneous event with one of the following (revised by the Sponsor): 
 elevations in AST/ALT more than 2u baseline value and  uULN 
 fever >38°C or 100°F 
 eosinophils >1000/mm3 
 serum sickness-like reaction 
A Grade 4 rash is defined as: 
x exfoliative dermatitis OR 
x a generalized rash with mucous membrane involvement OR 
x erythema multiforme OR 
x Stevens-Johnson Syndrome OR 
x rash associated with necrosis requiring surgery 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 70 of 74 
x Subjects will permanently discontinue the intake of all study drug(s) and be withdrawn 
from the study with Grade 3 or 4 rash identified. No rechallenge is allowed. 
x An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
x Assessment of safety blood samples by the local laboratory is required on the day of initial 
rash evaluation and the day thereafter (days 1 and 2 of the rash), and as indicated below. 
A copy of the local laboratory report should be anonymized and will be retrieved by the 
monitor. 
x Digital pictures should be taken within 24 hours after the onset of the rash and on day 1 of 
the rash, and as indicated below. 
x Referral to a dermatologist is required, preferably within 24 hours after the onset of the rash. 
A copy of the dermatologist’s report should be anonymized and will be retrieved by the 
monitor. 
x A biopsy should be performed within 24 hours after the onset of the rash. A copy of the 
biopsy report should be anonymized and will be retrieved by the monitor. 
x Appropriate management should be undertaken and subjects should be followed until 
resolution of the rash. 
x The description of the rash should be reported per ‘Unscheduled Visit in Case of Rash’ in the 
eCRF (i.e., the initial rash assessment pages). The follow-up rash assessment pages of the 
eCRF should be completed for all follow-up visits. 
For close follow-up of the rash, unscheduled visits will be performed as follows: 
x Follow-up visits on days 2, 3, and 4 of the rash are required. Additional safety blood samples 
and digital pictures are to be taken on these days only if the subject’s AST/ALT on day 1 
and/or day 2 of rash >2u EDVHOLQHYDOXHDQGRU uULN and/or in case of rash progression. 
For these and all subsequent local laboratory blood sample assessments: a copy of the local 
laboratory report should be anonymized and will be retrieved by the monitor. 
x A follow-up visit on day 6 of the rash is required and additional safety blood samples 
and digital pictures are to be taken regardless of the day 1/2 AST/ALT levels or rash 
progression. 
x Thereafter, weekly follow-up visits are required (or more frequently at the Investigator’s 
discretion) as long as Grade 3–4 rash is present. Once Grade 3–4 rash has resolved to 
Grade 2, follow-up should be performed according to the instructions for follow-up visits 
for Grade 1 or Grade 2 rash, respectively. 
x As long as the rash remains Grade 3 or 4, additional safety blood samples and digital pictures 
are required at these weekly follow-up visits only if the subject’s AST/ALT on day 6 of rash 
is still >2u EDVHOLQHYDOXHDQGRU uULN and/or in case of rash progression, until 
resolution or stabilization of the AST/ALT elevations. 
Upon resolution/stabilization of the rash, digital pictures should be taken and the final rash 
assessment pages of the eCRF should be completed. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 71 of 74 
Subjects should be advised to contact the Investigator immediately if they notice any 
worsening of the rash. 
A complete summary of the guidelines for rash management is given in Appendix 5. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 72 of 74 
APPENDIX 5. VISIT SCHEDULE FOR RASH MANAGEMENT FOR 
ADULT SUBJECTS 
This visit schedule summarizes the visits and assessments to be performed in case of rash. At the 
Investigator’s discretion, additional visits and assessments may be performed. For all rashes, 
please also complete the specific rash assessment pages of the eCRF for all visits. Local 
laboratory blood sample assessments will be documented/collected as described in the text 
above. 
 
Grade 1 Rash 
Grade 2 Rash 
Grade 3 or 4 Rash 
Rash day 1 a 
x Study drug(s) MAY 
be CONTINUED. 
x Unscheduled visit 
for initial rash 
evaluation 
REQUIRED. 
x Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
x Digital pictures 
REQUIRED 
(within 24 h). 
x Referral to 
dermatologist 
ONLY IF rash 
diagnosis uncertain 
(within 24 h). 
x Study drug(s) MUST be permanently 
DISCONTINUED if the subject has 
a persistent (i.e., >5 days with no 
response to treatment) Grade 2 b 
rash considered related to CD388 by 
the Investigator. Rechallenge is NOT 
ALLOWED. 
x Unscheduled visit for initial rash 
evaluation REQUIRED. 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED 
(within 24 h). 
x Referral to dermatologist 
REQUIRED (within 24 h). 
x Biopsy IF ADVISED by 
dermatologist (within 24 h). 
x Study drug(s) MUST be 
permanently DISCONTINUED. 
Rechallenge is NOT ALLOWED. 
x Unscheduled visit for initial rash 
evaluation REQUIRED. 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED 
(within 24 h). 
x Referral to dermatologist 
REQUIRED (within 24 h). 
x Biopsy REQUIRED (within 24 h). 
Rash day 2 
x Follow-up visit 
REQUIRED. 
x Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
x Digital pictures 
REQUIRED. 
x Follow-up visit REQUIRED. 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED. 
x Follow-up visit REQUIRED. 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED. 
Rash day 3 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
x Follow-up visit REQUIRED. 
x Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2î baseline value, AND/OR 
5 î ULN, AND/OR in case of rash 
progression. 
Rash day 4 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
x Follow-up visit REQUIRED. 
x Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2î baseline value, AND/OR 
5 î ULN, AND/OR in case of rash 
progression. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.SQ.1.03 
CD388 Injection 
Amendment 1 
Confidential  
Page 73 of 74 
 
Grade 1 Rash 
Grade 2 Rash 
Grade 3 or 4 Rash 
Rash day 5 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
x Follow-up visit REQUIRED.  
x Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2î baseline value, AND/OR 
5 î ULN, AND/OR in case of rash 
progression. 
Rash day 6 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
x Follow-up visit REQUIRED. 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED. 
Rash day 7 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
No Rash follow-up visit required 
Rash day 8 
x Follow-up visit 
REQUIRED c 
x Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
x Digital pictures 
REQUIRED. 
x Follow-up visit REQUIRED c 
x Assessment of safety blood sample 
by local laboratory REQUIRED. 
x Digital pictures REQUIRED. 
No Rash follow-up visit required 
Further 
Visits 
If rash is unresolved 
after second follow-up 
visit, further visits 
(with local lab 
assessments and digital 
pictures) at the 
Investigator’s 
discretion. c 
If rash is unresolved after second 
follow-up visit: 
:LWK$67$/7LQFUHDVHî baseline 
value OR AST/ALT increase 
<5 î ULN: c 
x Weekly assessment of safety blood 
sample by local laboratory 
REQUIRED until resolution of 
AST/ALT abnormalities. 
x Weekly digital pictures REQUIRED 
until resolution of AST/ALT 
abnormalities. 
Without AST/ALT increase: further 
visits at the Investigator’s discretion. c 
x Weekly follow-up visits 
REQUIRED until resolution of 
Grade 3–4 rash to Grade 
(further follow-up visits according 
to Grade 1 or Grade 2 rash 
instructions) 
x Weekly assessment of safety blood 
sample by local laboratory and 
digital pictures REQUIRED as 
long as Grade 3 or 4 rash is present 
but only if on day 6 of rash 
AST/ALT >2î baseline value, 
AND/OR 5 î ULN, AND/OR in 
case of rash progression, until 
resolution of AST/ALT 
abnormalities. 
Upon Rash 
Resolution/
Stabilization d 
Complete final rash 
assessment pages of the 
eCRF/eSource and take 
digital pictures. 
Complete final rash assessment pages of 
the eCRF/eSource and take digital 
pictures. 
Complete final rash assessment pages 
of the eCRF/eSource and take digital 
pictures. 
a. Note that Day 0 of the rash is the first day of Investigator assessment and not the first day of rash as reported by the subject. 
b. All grades in this list are per the DAIDS Toxicity Grading Scale (DAIDS 2017). 
c. In case rash progresses from a Grade 1 or a Grade 2 to a higher grade, start follow-up schedule for Grade 2, 3, or 4 rash as 
appropriate. 
d. Stabilization: to be agreed upon in collaboration with the Sponsor 


Cidara Therapeutics, Inc.
Protocol CD388.SQ.1.03
CD388 Injection
Amendment 1
Confidential 
Page 74 of 74
APPENDIX 6.
INVESTIGATOR SIGNATURE
I have read and understand Protocol CD388.SQ.1.03 and I agree to the following:
x
To conduct the trial in compliance with GCP, with applicable regulatory requirement(s), 
with the protocol agreed to by the Sponsor and given approval/favorable opinion by the 
IRB/IEC
x
To comply with procedures for data recording and reporting
x
To permit monitoring, auditing, and inspection by the Sponsor, its designated 
representatives, and regulatory authorities 
x
To retain the essential documents in the Investigator/institution files until the Sponsor 
informs the Investigator or institution that these documents are no longer needed
INVESTIGATOR SIGNATURE
Investigator Signature
Date
Investigator Printed Name
Site Information
Site Number:
Site Name:
Site Address:
Altasciences Clinical Los Angeles, Inc.
14-Dec-2022
5630 Cerritos Avenue
Cypress, CA 90630
David Kim, MD
01229


Certificate Of Completion
Envelope Id: E29F400E70104117B194ECAEEEF2213B
Status: Completed
Subject: CD388.SQ.1.03_Final Protocol_AM1_12-Dec-2022
Source Envelope: 
Document Pages: 74
Signatures: 2
Envelope Originator: 
Certificate Pages: 3
Initials: 0
Joaquin Sosa
AutoNav: Enabled
EnvelopeId Stamping: Disabled
Time Zone: (UTC-08:00) Pacific Time (US & Canada)
6310 Nancy Ridge Dr
STE 101
San Diego, CA  92121
jsosa@cidara.com
IP Address: 136.49.136.134 
Record Tracking
Status: Original
             12/13/2022 4:06:35 PM
Holder: Joaquin Sosa
             jsosa@cidara.com
Location: DocuSign
Signer Events
Signature
Timestamp
Taylor Sandison, MD. MPH
tsandison@cidara.com
Chief Medical Officer
Cidara Therapeutics Part 11
Security Level: Email, Account Authentication 
(Required)
Signature Adoption: Pre-selected Style
Signature ID: 
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With Signing Authentication via DocuSign password
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   I approve this document
Sent: 12/13/2022 4:23:12 PM
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Electronic Record and Signature Disclosure: 
      Not Offered via DocuSign
David Kim, MD
YKim@altasciences.com
Principal Investigator
Security Level: Email, Account Authentication 
(Required)
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ELECTRONIC RECORD AND SIGNATURE DISCLOSURE  
By accepting this notice, I am documenting that I understand and approve the following:  
1. When I sign documents or data electronically, I am accountable and responsible for all 
items thus signed. 
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
	




SAP_001.pdf: 
Statistical Analysis Plan 
 
 
Title: 
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to 
Determine the Safety, Tolerability, and Pharmacokinetics of CD388 
Subcutaneous Administration in Healthy Japanese Subjects 
NCT Number: 
NCT05619536 
Document Date: 
29 JUN 2023 
 


 
 
STATISTICAL ANALYSIS PLAN 
 
 
For: 
Cidara Therapeutics Inc. 
 
PROTOCOL No. CD388.SQ.1.03 
 
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, 
Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese 
Subjects 
 
 
Altasciences Project No. CID-P2-387 
 
Prepared by: 
Altasciences Company Inc. 
575 Armand-Frappier Boulevard 
Laval, Quebec 
Canada, H7V 4B3 
 
 
Version: 1.0 
Date: 2023/06/29 
 


Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29
Page 2 of 28
STATISTICAL ANALYSIS PLAN APPROVAL
We have carefully read this statistical analysis plan and agree it contains the necessary 
information required to handle the statistical analysis of study data.
Logan Kowallis
Altasciences Senior Biostatistician
Date 
Prabhjot Kaur
Altasciences Pharmacokinetic Scientist
Date 
On behalf of the Sponsor:
Ozlem Equils, MD
Sr. Medical Director
Sponsor Representative
Date 


p



 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 3 of 28 
VERSION CONTROL 
Version 
Date 
Author 
Description of Changes 
1.0 
2023/06/29 
Logan Kowallis 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 4 of 28 
TABLE OF CONTENTS 
STATISTICAL ANALYSIS PLAN APPROVAL ..........................................................................2 
VERSION CONTROL ....................................................................................................................3 
TABLE OF CONTENTS .................................................................................................................4 
TABLE OF TABLES ......................................................................................................................6 
ABBREVIATIONS .........................................................................................................................7 
1 
INTRODUCTION ..................................................................................................................8 
2 
STUDY OBJECTIVES ..........................................................................................................8 
3 
STUDY DESIGN ...................................................................................................................9 
3.1 
General Description ...........................................................................................................9 
3.3 
Study Procedures ...............................................................................................................9 
3.4 
Randomization and Unblinding Procedures ......................................................................9 
4 
ANALYSIS POPULATIONS ..............................................................................................10 
5 
STUDY SUBJECTS ............................................................................................................11 
5.1 
Disposition .......................................................................................................................11 
5.2 
Protocol Deviations .........................................................................................................11 
6 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS ...............................11 
7 
PHARMACOKINETIC ANALYSIS ..................................................................................12 
7.1 
Pharmacokinetic Analysis ...............................................................................................12 
7.1.1 
Missing Values.......................................................................................................12 
7.1.2 
Measurements Below the Lower Limit of Quantitation ........................................12 
7.1.3 
Actual Time ...........................................................................................................13 
7.1.4 
Non-Compartmental Analysis ...............................................................................13 
7.1.5 
Pharmacokinetic Statistical Methodology .............................................................14 
7.1.6 
Summary Statistics .................................................................................................15 
8 
SAFETY ANALYSIS ..........................................................................................................15 
8.1 
Adverse Events ................................................................................................................18 
8.2 
Clinical Laboratory Evaluations ......................................................................................18 
8.3 
Vital Signs .......................................................................................................................22 
8.4 
Physical Examination Findings .......................................................................................23 
8.5 
Electrocardiogram ...........................................................................................................23 
8.6 
Reactogenicity/Injection Site Inspection .........................................................................23 
9 
pharmacogenomics and biomarker evaluations ...................................................................23 


 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 5 of 28 
10 
AntiDrug Antibodies ............................................................................................................23 
11 
DATA HANDLING AND PRESENTATION ....................................................................23 
11.1 Safety Analysis Presentation ...........................................................................................24 
11.2 Pharmacokinetic Analysis ...............................................................................................25 
11.3 Analysis Timepoints  .......................................................................................................25 
11.4 Methods for Handling Missing Data ...............................................................................25 
12 
INTERIM ANALYSES AND DATA SAFETY MONITORING .......................................25 
13 
GENERAL INFORMATION RELATED TO DATA PRESENTATIONS ........................26 
APPENDIX A 
STUDY SCHEDULE(S) ..............................................................................27 


 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 6 of 28 
TABLE OF TABLES 
Table 1: 
Objectives and Related Endpoints .......................................................................... 8 
Table 2: 
Data presentations for study subject information ................................................. 11 
Table 3: 
Data presentations for demographic and other baseline characteristics ............... 12 
Table 4: 
PK Parameter Term Definitions ............................................................................ 13 
Table 5: 
Data Presentations for Safety Assessments .......................................................... 16 
Table 6: 
Clinical Laboratory Evaluations ........................................................................... 18 
Table 7: 
PCS Values for Hematology ................................................................................. 20 
Table 8: 
PCS Values for Serum Chemistry......................................................................... 20 
Table 9: 
PCS Values for Lipids .......................................................................................... 21 
Table 10: 
PCS Values for Coagulation ................................................................................. 22 
Table 11: 
PCS Values for Urinalysis .................................................................................... 22 
Table 12: 
PCS Values for Vital Signs ................................................................................... 22 
 


 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 7 of 28 
ABBREVIATIONS 
Ȝ] 
elimination rate constant 
ADA 
Anti-drug antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ANOVA 
analysis of variance 
ATC 
anatomical therapeutic chemical 
BMI 
body mass index 
CI 
confidence interval 
CRF 
case report form 
CSR 
clinical study report 
CV% 
coefficient of variability 
DMP 
data management plan 
ECG 
electrocardiogram 
EOS 
end of study 
ET 
early termination 
HEENT 
head, eyes, ears, nose, throat 
HR 
heart rate 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ln 
natural log 
MedDRA 
Medical Dictionary for Regulatory Activities 
PCS 
potentially clinically significant 
PI 
Principal Investigator 
PK 
pharmacokinetic(s) 
PP 
per protocol 
PT 
preferred term 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SE 
standard error 
SOC 
system organ class 
SOP 
standard operating procedure 
SQ 
subcutaneous 
TEAE 
treatment-emergent adverse event 
TFLs 
tables, figures, and listings 
WHO-DDE 
World Health Organization Drug Dictionary- Enhanced 
 
 


 
 
 
Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29 
Page 8 of 28 
1 
INTRODUCTION 
This study is a randomized, double-blind, single ascending dose study to determine the safety, 
tolerability, and pharmacokinetics of CD388 subcutaneous administration in healthy Japanese 
subjects. 
This statistical analysis plan (SAP) provides a detailed description of the statistical methods and 
procedures to be implemented for the analyses of data from protocol CD388.SQ.1.03. Pre-planning 
of analyses reduces the potential for bias and often reduces disputes between sponsor and the 
regulatory authority regarding the validity of the results. The same principles apply to supportive 
and/or sensitivity analyses. These analyses must be prospectively specified. (Good Review 
Practice: Clinical Review of Investigational New Drug Applications, December 2013).  
The analyses described in the SAP are based upon the final protocol version, Amendment 1, 
dated 2022/12/12. 
2 
STUDY OBJECTIVES 
The objectives of the study and corresponding study endpoints are detailed in Table 1. 
Table 1: 
Objectives and Related Endpoints 
Objective 
Endpoint 
Analysis 
Primary  
To evaluate safety and 
tolerability of CD388 in healthy 
Japanese adult subjects 
Adverse events (AEs) vital signs, 
electrocardiograms (ECGs), and 
physical exam 
 
Refer to Section 8 
Secondary  
To determine the plasma 
pharmacokinetic (PK) profile of 
CD388 Injection when dosed by 
SQ (subcutaneous) 
administration as a single dose to 
healthy Japanese adult subjects 
The following PK parameters for 
CD388 in plasma will be 
evaluated: 
Cmax, Tmax, AUC0-last, AUC0-, 
t1/2, CL/F, and Vz/F 
Refer to Section 7.1 
Exploratory  
 
 
To evaluate the PK profile of 
CD388 in upper respiratory tract 
after SQ administration as a 
single dose to healthy Japanese 
adult subjects 
The following PK parameters for 
CD388 in nasopharyngeal 
samples will be evaluated: 
Cmax, Tmax, AUC0-last 
Refer to Section 7.1 
To evaluate biomarkers 
that may be associated 
with safety, 
reactogenicity, and 
immunogenicity after 
CD388 Injection 
Results of the analyses of 
exploratory biomarkers 
(including but not limited to 
cytokines, chemokines, acute 
phase reactants, etc.) 
Refer to Section 9 


 
 
 
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Objective 
Endpoint 
Analysis 
To evaluate CD388 
immunogenicity 
Anti-drug antibody (ADA) titers 
in blood (plasma or serum) 
Refer to Section 10 
3 
STUDY DESIGN  
3.1 
General Description 
Cohort 1 will have 7 subjects receiving CD388 Injection and 2 subjects receiving placebo. If 
Cohort 2 is deemed appropriate to recruit, it will also have 7 subjects receiving CD388 Injection 
and 2 subjects receiving placebo. If Cohort 3 is deemed appropriate to recruit, it will follow the 
same process as Cohorts 1 and 2 and will have 7 subjects receiving CD388 Injection and 2 
subjects receiving placebo. 
Cohort 1 receives 50 mg of study drug injected subcutaneously (SQ). Cohort 2 receives 150 mg 
of study drug injected  subcutaneously. Cohort 3 receives 450 mg of study drug  injected 
subcutaneously. 
A total possible 27 subjects will be enrolled in this study; 21 to receive CD388 Injection and 6 to 
receive placebo. No formal sample size calculation was used in determining sample size. 
Subjects exhibiting Respiratory Tract Infection symptoms and who visit outpatient facilities for 
care will also have those visits summarized in addition to scheduled visits. 
3.2 
Investigational Product 
 The following will be administered to subjects based on the randomization schedule: 
x CD388 (Investigational product) 
CD388 Injection is a clear to lightly opalescent liquid essentially free of particulate 
matter containing the active pharmaceutical ingredient, CD388. CD388 Injection is 
supplied as a frozen sterile solution in single-use vials.  
x Placebo 
Normal saline will be administered SQ as the placebo control.   
3.3 
Study Procedures 
For complete details on the study assessments to be performed for each study period, refer to 
APPENDIX A.  
3.4 
Randomization and Unblinding Procedures 
Within each dose level (Cohorts 1, 2, and 3), subjects will be randomized to receive a single dose 
of CD388 Injection or saline placebo (treatment assignment is blinded). The study site’s 
pharmacist (or pharmacist designee) will obtain a computer-generated study drug assignment. A 
subject is considered randomized when a randomization transaction is appropriately recorded.  
All blinded study personnel (including the Sponsor directly involved in study conduct, 
Investigator, and site personnel directly involved in study conduct) and subjects will remain 
blinded to study drug assignment until the study is completed and the final database is locked 
with the exception of the unblinded pharmacy personnel, pharmacy monitor, and unblinded 
Sponsor personnel (such as Data Review Committee, clinical supply manager, PK lead, and 


 
 
 
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quality manager) who may be unblinded to study medication at any time during study conduct. 
The pharmacy monitor will monitor study drug preparation and accountability during the study 
and cases in which unblinding is required due to a safety or tolerability issue. To maintain study 
blinding, study drug preparation will be performed by an unblinded site pharmacist (or qualified 
unblinded personnel at the study site not involved with study procedures or evaluations).  
Only in the case of an emergency, when knowledge of the study drug is essential for the clinical 
management or welfare of a specific subject, may the Investigator unblind a subject’s study drug 
assignment. 
As soon as possible and without revealing the subject’s study drug assignment (unless important 
to the safety of subjects remaining in the study), the Investigator must notify the Sponsor if the 
blind is broken for any reason. The Investigator will record in source documentation the date and 
reason for revealing the blinded study drug assignment for that subject.  
As PK samples from subjects assigned to placebo treatment will not be analyzed for 
determination of CD388 concentrations, the bioanalytical laboratory will receive the 
randomization list to allow for correct selection of the samples. Unblinding of the randomized 
treatment assignment will be performed at the bioanalytical laboratory. Specific procedures will 
be in place to ensure that randomized treatment assignment will not be revealed to anyone 
involved in the execution of the study. 
4 
ANALYSIS POPULATIONS 
The following populations are defined for this study: 
x Enrolled Population 
All subjects who provided informed consent and are randomized, regardless of whether 
or not the subject received study drug. 
x Safety Population  
The safety population includes all subjects who receive any amount of study drug. 
x Pharmacokinetic (PK) Population 
The PK population will include all subjects who have received CD388 injection with at 
least 1 post dose time point. Subjects who do not complete the sampling schedule may be 
included in the PK analysis for only the PK parameters that are judged not to be affected 
by the missing sample(s).  


 
 
 
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5 
STUDY SUBJECTS 
Unless otherwise specified, all available data will be listed and summary tables for disposition 
and protocol deviations will be presented for the safety population as described in Table 2.   
Table 2: 
Data presentations for study subject information  
Data 
Variables 
Presentation 
Disposition and analysis 
population 
Subject completion status (i.e., 
completed or withdrawn), reason for 
withdrawal, analysis population 
determination 
Listings: 
x 
Disposition 
x 
Analysis population 
x 
Randomization 
Summary table including: 
x 
Number of subjects enrolled 
x 
N and % of subjects who 
completed the study 
x 
N and % of subjects 
discontinued from the study 
by primary reason for 
discontinuation and overall 
Protocol deviations 
Protocol deviations 
Listings: 
x 
General deviations 
x 
Pharmacokinetic (PK) 
sample collection time 
deviations 
x 
Major deviations 
5.1 
Disposition 
Subject disposition will be summarized for all subjects in the Enrolled population.  The 
percentages will be calculated using the number of subjects in each cohort and study drug group 
in the Enrolled population as the denominator.  
A listing of subject’s disposition will be provided. A listing of subjects included in each of the 
analysis populations will also be provided. The randomization scheme listing will also be 
provided. 
5.2 
Protocol Deviations 
Deviations will be collected by the clinic and presented as entered in a general protocol deviation 
listing.  For PK sampling time deviations, information will be derived programmatically and 
presented in a separate listing. Major deviations will also be listed in their own listing. 
6 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Unless otherwise specified, all available data will be listed and summary tables for demographics 
and other baseline characteristics will be presented for the Safety population as detailed in 
Table 3.   


 
 
 
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Table 3: 
Data presentations for demographic and other baseline characteristics  
Data 
Variables 
Presentation 
Demographics and other 
Baseline characteristics 
Sex, age, ethnicity, race, height (cm), 
body weight at screening (kg), and 
body mass index (BMI) (kg/m2) 
Listing 
Summary Table 
Medical history 
All medical history findings 
Listing 
Note: includes coded terms 
(system organ class [SOC] and 
preferred term [PT]) 
Prior medications 
All medications taken 30 days prior 
to study drug administration  
(including prescription medications, 
nonprescription medications, dietary 
supplements, vitamins, or herbal 
medications) 
Listing 
Note: includes coded terms 
(anatomic therapeutic chemical 
[ATC] level 4 and preferred 
name) 
Lifestyle 
Drinking habits 
Listing 
Contraception 
Contraceptive method 
Listing 
 
The medical history at screening will include all queries by the medical and clinical staff related 
to the subject’s well-being and history of relevant past medical events/experiences. Medical 
history will be coded to Medical Dictionary of Regulatory Activities (MedDRA) terms version 
25 and listed by subject. 
Prior medication will be coded using the World Health Organization Drug Dictionary Global 
dated March 2022 and will be listed by subject. 
7 
PHARMACOKINETIC ANALYSIS 
The PK analysis will be carried out according to Altasciences Standard Operating Procedures 
(SOPs). 
7.1 
Pharmacokinetic Analysis 
7.1.1 Missing Values 
The lack of concentration values due to failure to collect the sample, a lost or compromised 
sample or due to the subject’s early termination from the study will be termed “missing” in the 
dataset, and no imputation will be done. Predose samples collected can be set to 0. 
If the actual collection time of a postdose PK sample is unknown, but a valid concentration value 
has been measured, the sample will be set to missing in the PK analysis; it will be presented in 
listing but excluded from descriptive statistics.  
7.1.2 Measurements Below the Lower Limit of Quantitation 
Concentration values below the LLOQ associated with predose and postdose collection times up 
to the first quantifiable sample will be assigned a value of zero, and with postdose collection 
times after first quantifiable sample will be replaced with missing for the non-compartmental 
analyses (NCA), mean PK profile representations as well as for descriptive statistic calculations. 


 
 
 
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Descriptive statistics will not be determined for time points with more than 1/3rd of points 
missing.   
7.1.3 Actual Time 
The unknown and duplicate actual time will be managed as per Altasciences SOPs. 
The plasma NCA analysis will be based on the actual sampling times, except for predose 
samples, which will always be reported as zero, regardless of time deviations, provided that they 
were collected prior to dosing. A scheduled pre-dose sample collected after dosing will be set to 
missing in the PK analysis and its actual time will not be used and documented as appropriate. 
The individual plasma concentration/time profiles will be presented using actual sampling times 
whereas the mean plasma concentration/time profiles and tables presenting summary statistics of 
concentration-time series will be presented using nominal sampling times. 
Actual times of the plasma samples will be listed in the report. 
7.1.4 Non-Compartmental Analysis 
The following configuration for the NCA analysis (with Phoenix® WinNonlin® version 8, or 
higher) will be used: 
Data: 
                              Serial sampled data 
Model/Dose options Type:   
Plasma (200 202)/Extravascular  
AUC Calculation Method:  
Linear up/Log down  
Lambda Z (Ȝz) calculation:  
%HVWILWPHWKRGIRUȜz Linear-Log regression 
Reasons for excluding PK parameters will include the following: 
x AUC: AUC parameters will not be estimated if less than 3 consecutive 
measurable concentrations are observed. 
x 3.SDUDPHWHUVUHTXLULQJȜ]HVWLPDWLRQHJ$8&0- , CL/F, VZ/F, and t1/2) will 
be set to Not Reported (NR) in the tables and listings if they meet the following: 
o /HVVWKDQSRLQWVIRUȜz estimation 
o R2 < 0.8 
A list of PK Parameter terms and definitions are found in Table 4. 
Table 4: 
PK Parameter Term Definitions 
PK Parameter 
Definition 
Plasma PK 
Cmax 
Maximum observed plasma concentration 
tmax 
Time to reach the maximum plasma concentration; if it occurs at 
more than one time point, Tmax is defined as the first time point 
with this value 


 
 
 
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PK Parameter 
Definition 
AUC0-last 
Area under the plasma concentration-time curve from time 0 to 
time of the last quantifiable concentration 
AUC0- 
Area under the plasma concentration-time curve from time 0 to 
infinite time, calculated as the sum of AUClast and Clast/Oz, in 
which Clast is the last observed quantifiable concentration 
CL/F 
Apparent clearance, calculated as Dose/AUC 
Vz/F 
Apparent Volume of distribution,  FDOFXODWHGDV'RVHȜz 
*AUC 
t1/2 

Terminal elimination half-life, calculated as 0.693/Oz 
Upper Respiratory Tract (Nasopharyngeal) PK 
Cmax 
Maximum Nasopharyngeal concentration 
Tmax 
Time to reach the maximum Nasopharyngeal concentration; if it 
occurs at more than one time point, Tmax is defined as the first time 
point with this value 
AUC0-last 
Area under the Nasopharyngeal concentration-time curve from 
time 0 to time of the last quantifiable concentration 
The following plasma PK parameters will be used for PK calculation and presented in 
the PK listings only  
Tlast 
Time of last measurable observed concentration 
Clast 
Observed concentration corresponding to Tlast 
ȜZ 
Terminal slope (Oz) of the semi-logarithmic drug concentration-
time curve 
ȜZ Upper 
8SSHUOLPLWRQWLPHIRUYDOXHVLQFOXGHGLQWKHFDOFXODWLRQRIȜz 
ȜZ Lower 
/RZHUOLPLWRQWLPHIRUYDOXHVLQFOXGHGLQWKHFDOFXODWLRQRIȜz 
R2 
Goodness of fit for the terminal elimination phase 
AUC%extrap 
Extrapolated area (i.e., percentage of AUC due to extrapolation 
from Tlast to infinity) 
7.1.5 Pharmacokinetic Statistical Methodology 
All PK tables, figures and listings (TFLs), when appropriate, will be stratified by cohort. 
Individual and mean plasma concentration-time profiles will be presented on linear and semi-log 
scales.  


 
 
 
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7.1.6 Summary Statistics 
Summary statistics of the plasma and nasopharyngeal concentration data and derived parameters 
will be calculated for the PK population, unless otherwise indicated. Summary statistics will be 
calculated for concentration at each individual time point and for all PK parameters.  
Concentration data will be summarized by cohort using the following statistics: number of 
observations (N), arithmetic mean (mean), standard deviation (SD), minimum (min), median, 
maximum (max), and coefficient of variation (CV%). PK parameters will be summarized using 
these same statistics, as well as geometric mean and geometric mean CV. 
If a PK parameter value is reportable in less than 3 subjects for a cohort, then SD, CV%, and 
geometric mean CV will be considered not reportable. 
8 
SAFETY ANALYSIS 
Unless otherwise specified, all available data will be listed and summary tables for safety 
assessments will be presented for the safety population as detailed in Table 5.  


 
 
 
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Table 5: 
Data Presentations for Safety Assessments  
Data 
Variables 
Presentation 
Adverse events 
Adverse event (AE) 
description, date (study day) 
and time of onset and 
resolution, severity, 
relationship to study drug, 
action taken, and outcome 
(e.g., study discontinuation) 
Listings: 
x 
Reported AEs, 
x 
Serious adverse events (SAEs), 
x 
Adverse events of special 
interest (AESIs) 
Summary tables, including number and 
percentage of subjects experiencing: 
x 
Treatment-emergent adverse 
events (TEAEs), 
x 
TEAEs by severity,  
x 
TEAEs by relationship to study 
treatment (i.e., related or 
unrelated) 
x 
Serious TEAEs,  
x 
TEAEs leading to withdrawal 
x 
TEAEs with an outcome of 
death. 
Overall summary will include:  
x 
At Least One TEAE 
x 
At Least One Drug-Related 
TEAE 
x 
Maximum Severity by grading 1 
through 5 
x 
At Least One SAE 
x 
At Least One Drug-Related SAE 
x 
Deaths 
Note: includes coded terms (system 
organ class [SOC] and preferred term 
[PT]) 
Concomitant 
medications 
All medications taken during 
the study (as defined in the 
protocol and including prior 
medications that are 
continued), dose, units, route, 
indication/ reason taken, and 
date and time 
Listing 
Note: includes coded terms (anatomic 
therapeutic chemical [ATC] level 4 and 
preferred name) 
Extent of exposure 
Study drug administration 
dose, date, time,  
Listing 
Clinical laboratory 
evaluations 
Laboratory results (see Table 6 
for categories) 
Listings 
x 
all laboratory values by category,  


 
 
 
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Data 
Variables 
Presentation 
x 
Subjects with a potentially 
clinically significant (PCS) 
laboratory value by category 
Summary tables 
x 
Summary tables of laboratory 
values and change from baseline 
by visit 
x 
Number and percentage of 
subjects with at least one 
postbaseline laboratory value 
that is deemed as PCS by 
parameter 
x 
Number and percentage of 
subjects with a laboratory value 
that is deemed PCS, for each 
scheduled postbaseline 
assessment time point 
Vital signs 
Blood pressure, pulse, 
respiration rate, and body 
temperature 
Listings 
x 
all vital signs values 
x 
PCS vital sign values  
Summary table 
x 
Summary tables of vital signs 
values and change from baseline 
by visit and timepoint. 
x 
Number and percentage of 
subjects with at least one post 
baseline PCS value will be 
summarized for the worst post 
baseline value. 
x 
Number and percentage of 
subjects with a vital sign value 
that is PCS, for each scheduled 
postbaseline assessment time 
point 
Physical examination 
Physical examination findings 
Listings 
x 
all physical examination findings 
Electrocardiograms 
(ECGs) 
ECG interpretations and 
findings 
Listings 
x 
all ECGs 
x 
clinically significant ECGs 
Summary table 
x 
Summary tables of ECGs 
parameters values and change 


 
 
 
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Data 
Variables 
Presentation 
from baseline by visit and 
timepoint. 
x 
Categorical QTCF presentation 
of outliers by visit and timepoint. 
Reactogenicity/Injection 
Site Inspection 
 
Summary table 
x 
all reactions overall and by 
severity 
Listing 
x 
all reactions 
Note: Sub-bullets denote individual listings or tables to be generated. 
8.1 
Adverse Events 
An AE is defined as any untoward medical occurrence in a clinical investigation subject 
administered an investigational product and which does not necessarily have a causal 
relationship with the treatment. An AE can therefore be any unfavorable and unintended sign 
(including a clinically significant abnormal laboratory finding, for example), symptom, or 
disease temporally associated with the use of an investigational product, whether or not related to 
the investigational product. 
Treatment emergent adverse events (TEAEs) are AEs not present prior to the exposure to study 
treatment or AEs already present that worsen in intensity or frequency following exposure to 
study treatment. All AEs with a start date on or after exposure to study treatment are considered 
TEAEs. All summary tables (except where noted) will present TEAEs.  If a subject has more 
than one TEAE with the same PT, it is counted once in the summary tables at the strongest 
relationship to study drug and at the highest severity. 
Frequency tables summarizing all TEAEs, TEAEs by relationship, TEAEs by severity, Serious 
TEAEs, TEAEs leading to withdrawal, and TEAEs with an outcome of death (including SOC 
and PT) will be presented by treatment (with all placebo subjects pooled) and cohort as described 
in Table 5. 
A listing of subjects with AESI anaphylaxis will be provided.  
8.2 
Clinical Laboratory Evaluations 
See Table 5 for details on listings related to laboratory data. Categories of laboratory data include 
hematology, coagulation, serum chemistry, and urinalysis. 
Specific hematology, clinical chemistry, urinalysis, coagulation, and serology parameters are 
listed in Table 6. 
Table 6: 
Clinical Laboratory Evaluations 
Laboratory 
Test 
Category 
 
Specific Laboratory 
Tests 
Hematology: 
Hemoglobin 
Neutrophils (absolute) 
Hematocrit 
Monocytes (absolute) 


 
 
 
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Laboratory 
Test 
Category 
 
Specific Laboratory 
Tests 
Erythrocyte (red blood count [RBC]) 
count 
Eosinophils (absolute) 
Quantitative platelet count 
Lymphocytes (absolute) 
Total leukocyte (white blood cell 
[WBC]) count 
Basophils (absolute) 
Mean corpuscular hemoglobin (MCH) 
Mean corpuscular volume (MCV) 
Serum 
Chemistry: 
Aspartate aminotransferase (AST) 
Calcium 
Alanine aminotransferase (ALT) 
CO2 or bicarbonate 
Alkaline phosphatase (ALP) 
Blood urea nitrogen (BUN) or urea 
Albumin 
Creatinine 
7RWDOELOLUXELQLIWRWDOELOLUXELQLVî
ULN with no evidence of Gilbert’s 
syndrome, then fractionate into direct 
and indirect bilirubin) 
Glucose 
Sodium 
Chloride 
Potassium 
Lipase 
Total protein 
Amylase 
Phosphorus 
Lactate dehydrogenase (LDH)  
Creatinine Clearance (Cockcroft-Gault) 
Complement C3, C4, CH50 
Lipids: 
Triglycerides 
Low Density Lipoproteins (LDL) 
Cholesterol, Total 
 
Coagulation: 
Activated partial thromboplastin time 
(aPTT) 
International normalized ratio for 
prothrombin time (INR/PT) 
Urinalysis: 
pH 
Occult blood 
Protein 
Specific gravity 
Glucose 
Ketones 
Appearance 
Color 
Bilirubin 
Leukocyte esterase 
Nitrite 
Microscopic reflex if protein, nitrite, 
blood or leukocyte esterase are positive 
(WBC, RBC, epithelial cells, bacteria, 
casts, other findings) 
Serology: 
Hepatitis B surface antigen (HBsAg) 
Human immunodeficiency virus 
(HIV) antibody 
Hepatitis C antibody 
Severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) polymerase 
chain reaction (PCR) 
Pregnancy 
Serum beta human chorionic 
JRQDGRWURSLQȕ-hCG) pregnancy test 
for females of childbearing potential 
(screening and 
Day 120 only), urine or serum test 
at all other specified visits 
Follicle-stimulating hormone (FSH), if 
applicable to confirm postmenopausal 
status, is only required once 


 
 
 
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Laboratory 
Test 
Category 
 
Specific Laboratory 
Tests 
Other 
Drug (opioids, benzodiazepines, barbiturates, cocaine metabolites, 
cannabinoids, methamphetamines, phencyclidine, amphetamine, 
cotinine) and alcohol screen 
Values for continuous laboratory categories (hematology, chemistry, urinalysis, and coagulation) 
will be summarized by visit and for the change from baseline using descriptive statistics. The 
number and percentage of subjects with at least one post baseline PCS value and value that is 
PCS, for each scheduled post baseline of each laboratory parameter will also be presented.  
Serology, alcohol/drug screen, and pregnancy test results will be presented in separate listings.  
Data listings will include out-of-range flags (L (low), H (high)) and whether the abnormal values 
are clinically significant or not (based on the PI determination) and an indication of whether the 
value meets the PCS criterion. 
Potentially clinically significant laboratory values (as defined in Table 7, Table 8, Table 9, Table 
10, and Table 11) will be listed by category.  
Table 7: 
PCS Values for Hematology 
Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
White blood cell count, thou/L 
4.3 - 11.0 
< 2.0, >25.0 
Absolute basophils, cells/L 
0 - 150 
> 400 
Absolute eosinophils, cells/L 
0 - 500 
> 800 
Absolute lymphocytes, cells/L 
1200 - 3700 
< 700, > 6000 
Absolute monocytes, cells/L 
20 - 1000 
< 10, > 2100 
Absolute neutrophils, cells/L 
1800 - 7200 
< 1000, > 9000 
Platelet count, thou/L 
150 - 450 
< 30,  > 700 
Red blood cell count million/uL 
 
 
Male 
4.3 - 5.7 
<  3.8 , > 6.4 
Female 
3.9 - 5.2 
<  3.3,  > 5.5 
Hematocrit, % 
 
 
Male 
40.0  –  51.0 
< 20.0,  > 60.0 
Female 
34.0  -  45.0 
< 20.0,  > 60.0 
Hemoglobin, g/dL 
 
 
Male 
13.5 – 17.5 
< 7.0,  > 18.0 
Female 
11.0 – 15.5  
<  7.0,  >18.0 
 
 
Table 8: 
PCS Values for Serum Chemistry 
Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
Alanine aminotransferase, U/L 
 
 
     Female 
0 – 40 
> 58 
    Male 
0 – 55 
>  92 


 
 
 
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Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
Albumin, g/dL 
3.5 – 5.2 
<  1.5,  > 6.0 
Alkaline phosphatase, U/L 
 
 
Female 
35 – 104 
 
Male 
40  – 129 
 
Amylase 
28 – 100 
 
Aspartate aminotransferase, U/L 
 
 
     Female 
0 – 35  
 
     Male 
0 – 50 
 
Carbon dioxide , mmol/L 
22 – 32 
< 10,  > 40 
Bilirubin total, mg/dL 
0 – 1.4 
> 7.0 
Blood urea nitrogen, mg/dL 
6 – 21 
>70 
Calcium, mg/dL 
8.4 – 10.6 
< 6.9,  > 12.6 
Chloride, mmol/L 
96 – 108 
< 65,  > 130 
Creatinine, mg/dL 
 
 
Female 
0.4 – 1.1 
> 7.4 
Male 
0.5 – 1.2 
> 7.4 
Creatinine Clearance (Cockcraft-Gault) 
> 80 
 
Direct Bilirubin, direct (conjugated), 
mg/dL 
0  – 0.3 
 
Glucose, nonfasting, mg/dL 
60 – 99 
< 40,  >400 
Lactate dehydrogenase U/L 
 
 
     Female 
135 – 214 
 
     Male 
135 – 225 
 
Lipase 
7 – 60 
> 200 
Magnesium mg/dL 
1.3 – 2.5 
< 0.9,  > 3.5 
Phosphorus mg/dL 
2.6 –  4.5 
< 1.4 ,  > 6.6 
Potassium, mmol/L 
3.4 – 5.4 
< 3.0,  > 6.5 
Protein, total g/dL 
6.3 – 8.3 
< 3.0, > 9.0 
Sodium, mmol/L 
133 – 145 
< 120, > 160 
 
Table 9: 
PCS Values for Lipids 
Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
Low Density Lipoproteins 
100 – 129 
< 30, > 150 
Cholesterol, Total  
120 – 199 
             > 200 
Triglycerides  
35 – 149 
             > 149 


 
 
 
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Table 10: 
PCS Values for Coagulation 
Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
Partial thromboplastin time, activated, sec 
24 – 35 
< 10, > 100 
Prothrombin time – INR  
0.9 – 1.1 
             > 5.0 
 
Table 11: 
PCS Values for Urinalysis 
Laboratory Parameter (Unit) 
Normal Reference Range 
Potentially Clinically 
Significant Range 
Bilirubin 
Negative 
1+ 
Glucose 
Negative 
1+ 
Ketones 
Negative 
1+ 
Leukocyte Esterase 
 
 
Male 
Negative 
1+ 
Female 
Negative 
1+ 
Nitrite 
Negative 
1+ 
Occult Blood 
 
 
Male 
Negative 
Trace 
Female 
Negative 
Trace  
Protein 
Negative 
1+ 
Specific Gravity 
1.003 – 1.035 
< 1.000  > 1.037 
pH, Urine 
5.0 – 8.0 
NA 
NA = not applicable. 
8.3 
Vital Signs 
Vital signs will include systolic and diastolic blood pressure, body temperature, pulse, and 
respiratory rate. 
Absolute and change from baseline values in vital signs measurements will be summarized 
descriptively by visit, and timepoint. A summary table of subjects with PCS values at any post 
baseline visit will be presented by visit.  
Potentially clinically significant vital signs values (as defined in Table 12) will be listed by 
parameters. 
Table 12: 
PCS Values for Vital Signs 
Parameter (Unit) 
Potentially Clinically 
Significant Range 
Systolic Blood Pressure (mmHg) 
<= 90, >= 140  
Diastolic Blood Pressure (mmHg) 
<= 60, >= 90 
Pulse Rate (beats/min) 
<= 50, >= 100 
Body Temperature (ၨC) 
<= 36, > 38  
Respiratory Rate (breaths/min) 
<= 12, >= 20 
 


 
 
 
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Data listings will identify if values are “abnormal, clinically significant” or “abnormal, not 
clinically significant” and an indication of whether the value meets the PCS criterion. 
8.4 
Physical Examination Findings 
The physical examination will include a general review of the following body systems: general 
appearance, head, eyes, ears, nose, throat (HEENT), neck / thyroid, respiratory, cardiovascular, 
gastrointestinal, genitourinary, neurological, musculoskeletal / extremities, skin and other. 
Physical examination results, with abnormal and clinically significant abnormal findings flagged 
will be listed.  
8.5 
Electrocardiogram 
ECG parameters to be listed include HR, PR, QRS, and QTcF. ECG results will be summarized 
descriptively by visit and timepoint and change from baseline will be presented. Data listings 
will identify if values are “abnormal, clinically significant” or “abnormal, not clinically 
significant”.   
Outliers with respect to QTcF will also be tabulated for the following categories: 
$EVROXWHYDOXH!PVHFDQGPVHF 
$EVROXWHYDOXH!PVHFDQGPVHF 
Absolute value > 500 msec 
Increase from baseline >= 30 msec and < 60 msec 
Increase from baseline >= 60 msec 
8.6 
Reactogenicity/Injection Site Inspection 
Reactogenicity/Injection Site Inspection will be summarized descriptively by CD388 dose, 
pooled placebo, visit, and time point. Also, worst severity score after each study drug injection 
will be summarized by CD388 dose and pooled placebo. Additionally, data listings will be 
provided.  
9 
PHARMACOGENOMICS AND BIOMARKER EVALUATIONS 
Additional blood samples will be collected for pharmacogenomics and exploratory biomarker 
evaluation.  
Analyses of DNA and biomarkers may be conducted at the Sponsor’s discretion and reported 
separately from the study report. 
10 ANTIDRUG ANTIBODIES 
Analysis of the ADA results will be determined and may include determination of subjects’ 
positive/negative ADA status at baseline, treatment-emergent ADA in subjects with a negative 
baseline, as well as post-baseline increase in titer for subjects with positive ADA at baseline. 
11 DATA HANDLING AND PRESENTATION 
All safety and statistical outputs will be generated using SAS software, version 9.4. 
Pharmacokinetic outputs will be generated using WinNonlin version 8.0 or higher. 
All programs used to generate statistical analyses will be validated according to Altasciences’s 
standard operating procedures (SOPs). 


 
 
 
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The analyses described in this plan are considered a priori, in that they have been defined prior to 
database lock and prior to breaking the blind.  Any analyses performed subsequent to database 
lock and breaking the blind that are not described within the present plan will be considered post 
hoc and exploratory.  Post hoc analyses will be labeled as such in the corresponding statistical 
output and identified in the clinical study report (CSR). 
11.1 Safety Analysis Presentation 
Adverse events and medical history will be classified using the Medical Dictionary for 
Regulatory Activities (MedDRA) terminology version 25.0.  
Prior and concomitant medications will be coded with the World Health Organization Drug 
Dictionary (WHODrug) version dated March 2022. 
In general, the data listings will include all enrolled subjects up to the point of study completion 
or discontinuation; exceptions will be listings pertaining to a subset of subjects only (e.g., 
subjects with protocol deviations) or a subset of records/events (e.g., abnormal laboratory 
values). 
For categorical variables, n and percentages will be presented. For continuous variables, mean, 
SD, median, min and max will be presented. 
The following general comments also apply to all statistical analyses and data presentations: 
x Duration variables will be calculated using the general formula: (end date - start date) +1. 
x If the reported value of a clinical laboratory parameter cannot be used in a statistical 
summary table (e.g., a character string is reported for a parameter of the numerical type), 
a coded value must be appropriately determined and used in the statistical analyses.  In 
generaODYDOXHIRUORZHUDQGXSSHUOLPLWRIQRUPDOUDQJHVXFKDVµ¶RUµ¶ZLOOEH
treated as ‘10’ or ‘5’ respectively, and a value such as ‘>100’ will be treated as ’100’.  
However, the actual values as reported in the database will be presented in data listings. 
x When assessments are repeated for a given time point, only the result which is the closest 
to the dosing time will be included in summary tables. 
x If there is an unscheduled assessment, the result will only be utilized for a given time 
point if it falls within the analysis window and there is no scheduled assessment at the 
given time point. 
In general, summary statistics for raw variables (i.e., variables measured at the study site or 
central laboratory) will be displayed as follows:  
x Minima and maxima will be displayed to the same number of decimal places as the raw 
data.  
x Means, medians, and quartiles will be displayed to 1 additional decimal place.  
x Standard deviations will be displayed to 2 additional decimal places.   
x Percentages will be displayed to 1 decimal place. Percentages between 0 and 0.1 
(exclusive) will be displayed as ‘<0.1’.   


 
 
 
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x Derived variables (i.e., variables that are not measured by the study site but are calculated 
for analysis based on other measured variables) will be displayed to 1 decimal place. 
Values between 0 and 0.1 (exclusive) will be displayed as ‘<0.1’. 
11.2 Pharmacokinetic Analysis 
In general, all PK summary tables will be presented for the PK population. 
Individual raw PK concentrations will be displayed with the same precision as received from the 
bioanalytical laboratory. 
Precision for individual PK parameters will be displayed as follows:  
x Cmax, AUCs, CL/F and VZ/F will be displayed with the same precision as the raw PK 
concentration data, 
x Parameters associated with time (e.g., time of maximum concentration [Tmax] and 
terminal elimination half-life [t1/2]) will be displayed with 2 decimal places, 
x Percentages will be displayed with 2 decimal places, 
x &RHIILFLHQWRIGHWHUPLQDWLRQ5DQGHOLPLQDWLRQUDWHFRQVWDQWȜz) will be displayed 
with 4 decimal places. 
Summary statistics for concentration and PK parameters will be displayed with the same 
precision as the individual values, with the exception of number of observations (N) and CV% 
which will be presented with 0 and 1 decimal place, respectively. 
11.3 Analysis Timepoints  
Unless otherwise specified, the baseline value will be defined as the last non-missing evaluation 
prior to the first dose of study medication. 
11.4 Methods for Handling Missing Data  
No imputations of values for missing data (i.e., blank, “Not Done”, “Not Applicable”, etc.) will 
be performed and data presentations will reflect the data point as it appears in the case report 
form (CRF) or electronic data file.  
12 INTERIM ANALYSES AND DATA SAFETY MONITORING 
After 50% of Cohort 1 subjects have completed study drug administration and have undergone 
protocol-VSHFLILHGSURFHGXUHVDQGDVVHVVPHQWVIRUGD\VWKH3ULQFLSDO,QYHVWLJDWRU3,DQG
Sponsor will review blinded safety data in tables and listings: AEs (including systemic 
reactogenicity/injection site reactions, hypersensitivity reactions, and AESIs), vital signs, 12-lead 
ECGs, and clinical laboratory results (hematology, coagulation, serum chemistry, urinalysis) to 
determine the safety and tolerability of the study drug. The incidence and severity of AEs, and 
any adverse changes in vital signs, clinical laboratory findings, and ECGs will be considered 
when determining safety and tolerability of study drug. If the dose is determined to be safe and 
ZHOOWROHUDWHGGD\VDIWHUGRVLQJ&RKRUWZLOOEHHnrolled. Enrollment of the remaining 50% 
of Cohort 1 will continue while the safety data of the first 50% of Cohort 1 is being reviewed.  
Cohort 3 will be evaluated for enrollment using the same rules for evaluating Cohort 2. 


 
 
 
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13 GENERAL INFORMATION RELATED TO DATA PRESENTATIONS 
The formats and layouts of TFLs are provided in a separate document and are common displays.  
Their numbering and general content follow the International Conference on Harmonisation 
(ICH) E3 guidelines.  Actual formats and layouts may be altered slightly from those presented as 
necessary to accommodate actual data or statistics.  Minor format changes will not require 
updates to the SAP, rather they may be documented in a Running Note to SAP. 
 


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APPENDIX A
STUDY SCHEDULE(S)
Abbreviations: AEs = adverse events; BMI = body mass index; BP = blood pressure, CBC = complete blood count; COVID-19 = coronavirus disease 2019; CRU = clinical 
research unit; DAR = drug-antibody ratio; ECG = electrocardiogram; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; HR = heart rate; hr = hour; ICF = informed consent form; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe acute respiratory 
syndrome coronavirus 2. 


 
 
 
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a. The timing of this visit is Day 120 for Cohort 1 and Day 165 for Cohorts 2 and 3. For subjects who discontinue study early, the Day 120/165 procedures 
should be performed.  
b. Weight should be measured at each of the outpatient visits (Days 30, 45, 60, 90, 120/165).  
c. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated, and will be measured with the subject in a seated position for at least 3 minutes prior to measurement.  
d. A triplicate 12-lead ECG is to be performed at screening, at CRU check-in on Day -1, predose (immediately prior to study drug administration) and 6 hours 
postdose (±10 minutes) on Day 1, and as indicated in the schedule. Subjects are to be resting (at least 5 minutes) and semi-recumbent when ECG is being 
conducted.  
e. Laboratory evaluations (including exploratory biomarker samples) need to be performed once during the Day 3–6 interval on Day 4.  
f. A sensitive serum preJQDQF\WHVWȕ-human chorionic gonadotropin) is required at screening and Day 120/165 for females of childbearing potential. Urine 
pregnancy test may be performed at all other time points.  
g. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see Appendix 2 of the protocol).  
h. At indicated visits, inspection of administration site and surrounding area will be performed twice daily (once between approximately 2–4 hours postdose, and 
once approximately 8–12 hours postdose, then twice daily on other indicated study days at least 6 hours apart), with any abnormal findings reported as AEs. 
Reactions will be rated according to the scale provided in Table 5 of the protocol.  
i. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 2, 4, and 12 hours (each ±10 minute window); 24 hours (±30 minute 
window); 48 hours (±1 hour window); 72, 96, 120 hours (each ±2 hour window); and in the morning on Days 7, 9, 11, 14. Postdose samples collected at 
outpatient CRU visits at Days 30, 45, 60, 90, and 120/165 have the same windows (i.e., in ±days) as the visits.  
j. A mandatory pharmacogenomic (DNA) blood sample will be collected once, preferably on Day 1 (collection at another time point is allowed if necessary) to 
allow for pharmacogenomic research related to CD388.  
k. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, and 30.  
l. Adverse events (including influenza-like illness which will be tested for both COVID-19 and flu) will be collected for all subjects from the time of signing the 
ICF through 7 months after study drug dosing.  
m. Concomitant medication and procedures, including those used to treat an AE, will be recorded from 28 days prior to the CD388 Injection/placebo 
administration until the final study visit.  
 


 

 
TABLE, FIGURE, AND LISTING 
SHELLS ADDENDUM TO SAP 
 
 
For: 
Cidara Therapeutics Inc. 
 
PROTOCOL No. CD388.SQ.1.03 
 
 
 
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, 
Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese 
Subjects 
 
 
Altasciences Project No. CID-P2-387 
 
 
 
Prepared by:  
Altasciences Inc. 
575 Armand-Frappier Boulevard 
Laval, Quebec 
Canada, H7V 4B3 
 
 
 
 
Version: 1.0 
Date: 2023/06/29 
 


 
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Page 2 of 53
VERSION CONTROL 
 
Version 
Date 
Author 
Description of Changes 
1.0 
2023/06/29 
Logan Kowallis 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 


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TABLE OF CONTENTS
VERSION CONTROL ........................................................................................................................... 2
TABLE OF CONTENTS........................................................................................................................ 3
INTRODUCTION .................................................................................................................................. 8
TABLE, FIGURE, AND LISTING SHELLS....................................................................................... 10
14
CLINICAL STUDY REPORT TABLES AND FIGURES........................................................................... 10
Demographic Data ................................................................................................................ 10
14.1.1.1.1
*Table* Template Disposition......................................................................................................................... 10
Table 14.1.1 Subject Disposition (All Subjects) ............................................................................10
Demographics ............................................................................................................... 11
14.1.2.1.1
*Table* Template: Demographics................................................................................................................... 11
Table 14.1.2.1 Summary of Demographic and Baseline Characteristics (Safety Population) .......11
Table 14.1.2.2 Summary of Demographic and Baseline Characteristics (Pharmacokinetic 
Population) .....................................................................................................................................13
Pharmacokinetic, Pharmacodynamic, and Efficacy Data..................................................... 14
Pharmacokinetic Data ................................................................................................... 14
14.2.1.1
Pharmacokinetic Concentration Summaries ............................................................ 14
Table 14.2.1.1.x Summary Statistics of CD388 Plasma Concentration Data Following a Single 
Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult 
Subjects(Pharmacokinetic Population)...........................................................................................14
Figure 14.2.1.1.x: Mean (+SD) Plasma Concentration-Time Profiles of CD388 Following Single 
Subcutaneous Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic 
Population (Pharmacokinetic Population)......................................................................................15
Figure 14.2.1.1.x: Mean (+SD) Nasopharyngeal Concentration-Time Profiles of CD388 
Following Single Subcutaneous Administration of CD388 to Healthy Japanese Adult 
Subjects(Pharmacokinetic Population (Pharmacokinetic Population) ...........................................15
14.2.1.2
Pharmacokinetic Parameter Summaries................................................................... 16
Table 14.2.1.2.1: Summary Statistics of Plasma PK Parameters of CD388 Following a Single 
Subcutaneous Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic 
Population) .....................................................................................................................................16
Table 14.2.1.2.2: Summary Statistics of Nasopharyngeal PK Parameters of CD388 Following a 
Single Subcutaneous Administration of CD388 to Healthy Japanese Adult 
Subjects(Pharmacokinetic Population)...........................................................................................16
14.2.1.3
Statistical Analysis of Pharmacokinetic Data .......................................................... 17
Table 14.2.1.3.1 Statistical Analysis for Dose Proportionality of AnalyteName Pharmacokinetic 
Parameters (Pharmacokinetic Population) .....................................................................................17
Safety Data............................................................................................................................ 18
Adverse Events ............................................................................................................. 18
14.3.1.1
Adverse Event Summary.......................................................................................... 18


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Table 14.3.1.1 Summary of Adverse Events  (Safety Population).................................................18
14.3.1.2
TEAE by SOC.......................................................................................................... 20
Table 14.3.1.2 Summary of Treatment-Emergent Adverse Events by System Organ Class and 
Preferred Term (Safety Population) ...............................................................................................20
14.3.1.3
Drug-Related TEAE Summary by SOC and PT...................................................... 21
Table 14.3.1.3 Summary of Drug-Related Treatment-Emergent Adverse Events by System Organ 
Class and Preferred Term (Safety Population)...............................................................................21
Listing of Deaths, Other Serious and Significant Adverse Events ............................... 22
Table 14.3.2.1 Listing of Death, Other Serious and Significant Adverse Events (Safety 
Population) .....................................................................................................................................22
Safety Assessments....................................................................................................... 23
14.3.4.1
Out of Range Lab ..................................................................................................... 23
Table 14.3.4.1.1 Listing of Out-of-Range Laboratory Values (Safety Population) .......................23
Table 14.3.4.1.2 Listing of Clinically Significant Laboratory Values ...........................................24
14.3.4.2
Summary Lab........................................................................................................... 25
Table 14.3.4.2.1.1 Summary of General Biochemistry (Safety Population)..................................25
Table 14.3.4.2.2.1 Summary of Hematology (Safety Population) .................................................26
Table 14.3.4.2.3.1 Summary of Coagulation (Safety Population) .................................................26
Table 14.3.4.2.4.1 Summary of Urinalysis (Safety Population).....................................................26
Table 14.3.4.2.4.1 Summary of Lipids (Safety Population)...........................................................26
Table 14.3.4.2.2.2 Summary of Subjects with Potentially Clinically Significant General 
Biochemistry (Safety Population) ..................................................................................................26
Table 14.3.4.2.2.2 Summary of Subjects with Potentially Clinically Significant Hematology 
(Safety Population).........................................................................................................................26
Table 14.3.4.2.3.2 Summary of Subjects with Potentially Clinically Significant Coagulation 
(Safety Population).........................................................................................................................26
Table 14.3.4.2.4.2 Summary of Subjects with Potentially Clinically Significant Urinalysis (Safety 
Population) .....................................................................................................................................26
Table 14.3.4.2.5.2 Summary of Subjects with Potentially Clinically Significant Lipids (Safety 
Population) .....................................................................................................................................26
Vital Signs Data............................................................................................................ 27
14.3.5.1
Clinically Significant Vital Signs............................................................................. 27
Table 14.3.5.1 Listing of Clinically Significant Vital Signs Values ..............................................27
14.3.5.2
Vital Signs Summary ............................................................................................... 28
Table 14.3.5.2 Summary of Vital Signs (Safety Population) .........................................................28


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Table 14.3.5.3 Summary of Subjects with Potentially Clinically Significant Vital Signs (Safety 
Population) .....................................................................................................................................29
Electrocardiogram Data ................................................................................................ 30
Table 14.3.6.1 Listing of Clinically Significant Electrocardiogram Assessments (Safety 
Population) .....................................................................................................................................30
14.3.6.1
ECG Summary ......................................................................................................... 31
Table 14.3.6.2 Summary of Electrocardiogram (Safety Population) .............................................31
Table 14.3.6.3 Summary of Electrocardiogram Outliers (Safety Population) ...............................32
Other Safety Data.......................................................................................................... 33
Table 14.3.7.1 Listing of Clinically Significant Physical Examination (Safety Population) .........33
Table 14.3.7.1 Summary of Reactogenicity/Injection-Site Inspection (Safety Population)...........34
16
APPENDICES................................................................................................................................... 35
Randomization Scheme and Codes............................................................................... 35
Listing 16.1.7 Randomization (Safety Population) ........................................................................35
Subject Data Listings............................................................................................................ 36
Discontinued Subjects................................................................................................... 36
Listing 16.2.1 Study Disposition (Safety Population)....................................................................36
Protocol Deviations....................................................................................................... 37
Listing 16.2.2.1 Protocol Deviations (Safety Population)..............................................................37
Listing 16.2.2.2 Major Protocol Deviations (Safety Population)...................................................37
Subjects Excluded from the Analysis ........................................................................... 38
Listing 16.2.3 Analysis Populations (Safety Population)...............................................................38
Demographic Data ........................................................................................................ 39
16.2.4.1
Demographic Characteristics ................................................................................... 39
Listing 16.2.4.1 Demographic Characteristics (Safety Population) ...............................................39
16.2.4.2
Medical History........................................................................................................ 40
Listing 16.2.4.2 Medical History (Safety Population)....................................................................40
16.2.4.3
Prior and Concomitant Medications......................................................................... 41
Listing 16.2.4.3 Prior and Concomitant Medication (Safety Population)......................................41
Compliance and/or Drug Concentration Data............................................................... 42
Listing 16.2.5 Investigational Product Administration (Safety Population) ..................................42
Individual Response Data ............................................................................................. 43
16.2.6.1
Pharmacokinetic Data .............................................................................................. 43


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Table 16.2.6.1.x Individual CD388 Plasma Concentration Data Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic 
Population) .....................................................................................................................................43
16.2.6.1.1
Individual PK Parameters ................................................................................................................................ 44
Listing 16.2.6.1.x Individual Plasma PK Parameters of CD388 Following Single Subcutaneous 
Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population)......44
Listing 16.2.6.2.x Individual Nasopharyngeal PK Parameters of CD388 Following Single 
Subcutaneous Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic 
Population) .....................................................................................................................................44
16.2.6.1.2
PK Sampling Times.........................................................................................................................................45
Listing 16.2.6.1.3.1.x Actual Pharmacokinetic Plasma Sampling Times Following a Single 
Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects 
(Pharmacokinetic Population) ........................................................................................................45
Listing 16.2.6.1.3.2.x Actual Pharmacokinetic Nasopharyngeal Sampling Times Following a 
Single Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects 
(Pharmacokinetic Population) ........................................................................................................45
Listing 16.2.6.1.3.3.x Deviations for Actual Pharmacokinetic Plasma Sampling Times Following 
a Single Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult 
Subjects (Pharmacokinetic Population)..........................................................................................45
Listing 16.2.6.1.3.4.x Deviations for Actual Pharmacokinetic Nasopharyngeal Sampling Times 
Following a Single Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese 
Adult Subjects (Pharmacokinetic Population)................................................................................45
Figure 16.2.6.1.x.y Individual Plasma Concentration-Time Profiles of CD388 Following a Single 
Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects 
(Pharmacokinetic Population) ........................................................................................................46
Listing 16.2.6.2.x.y Individual Nasopharyngeal Concentration-Time Profiles of CD388 Following 
a Single Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult 
Subjects (Pharmacokinetic Population)..........................................................................................46
Adverse Event Listings................................................................................................. 47
Listing 16.2.7.1 Adverse Events (Safety Population) ....................................................................47
Listing of Individual Laboratory Measurements by Subject ........................................ 48
Listing 16.2.8.1 General Biochemistry (Safety Population) ..........................................................48
Listing 16.2.8.2 Hematology (Safety Population)..........................................................................49
Listing 16.2.8.3 Serology (Safety Population) ...............................................................................49
Listing 16.2.8.4 Urine Drug Screen (Safety Population) ...............................................................49
Listing 16.2.8.5 Urinalysis (Safety Population) .............................................................................49
Listing 16.2.8.6 Other Laboratory Tests (Endocrinology) (Safety Population).............................49
Listing of Other Individual Measurements by Subject................................................. 50
16.2.9.1
Vital Signs................................................................................................................ 50


 
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Listing 16.2.9.1 Vital Signs (Safety Population) ............................................................................50 
Listing 16.2.8.7 Reactogenicity/Injection Site Inspection (Safety Population) ..............................51 
16.2.9.2 ECG .......................................................................................................................... 52 
Listing 16.2.9.2 Electrocardiogram Assessments (Safety Population)...........................................52 
16.2.9.3 Physical Examination ............................................................................................... 53 
Listing 16.2.9.3 General Physical Examination (Safety Population) .............................................53 
 


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INTRODUCTION
The table, figure, and listing (TFL) shells describe the TFLs that will be programmed during the analysis 
and reporting of CD388.SQ.1.03.
These TFLs are common data displays. The numbering and general content follow the International 
Conference on Harmonisation (ICH) E3 guidelines and they are organized as they will appear in the 
Clinical Study Report (CSR).  
The TFL shells should be read in conjunction with the Clinical Study Protocol, Case Report Form 
(CRF), and Statistical Analysis Plan (SAP). This version of the shells has been developed using Clinical 
Study Protocol version Amendment 1, dated 12-DEC-22 and CRF version 2.0, dated 19-JAN-23. 
Finalization and approval of the SAP prior to the planned database lock is considered to cover the 
finalization and approval of the TFL shells as well. 
Modifications may be necessary to the planned TFL shell presentation to accommodate data collected 
during the study conduct. Significant changes, as deemed appropriate, will be documented in a Running 
Note to SAP. 
Common Presenation
The following common presentation will be considered as default unless otherwise defined.
Page Size and Margins
Tables, figures, and listings will be displayed on letter size paper, 8.5 inches by 11 inches, with the 
following margins (in inches): 
Orientation
Top
Bottom
Left
Right
Landscape
0.75
0.5
0.5
0.5
Portrait
0.5
0.5
0.75
0.5
Font Type and Size
Courier New, size 8
Header and Footer
The following header and footer will be presented in each TFL, unless otherwise specified:
CIDARA THERAPEUTICS INC.
Altasciences
Project #  CID-P2-387 / CD388.SQ.1.03
     Page 1 of x
Contents
Date: VERSION – YYYY-MM-DD
Data Source: XXXX
Program Source:  XXXXX.sas
Footnote


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In footnote section, present in the following order, as applicable:
x
Abbreviations
x
Note(s)
x
Numbered or lettered footnotes, eg, [1], [2], [a], [*], …
Treatment/Group Presentation
The following treatment or group termes will be presented, unless otherwise specified:
Treatment Description
Code
Shortened Term
Cohort 1: 50 mg CD388
A
50 mg CD388
Cohort 2: 150 mg 
CD388
B
150 mg CD388
Cohort 3: 450 mg 
CD388
C
450 mg CD388
Placebo
D
Pooled Placebo
All subjects, IP or 
Placebo given
E
Overall or All Subjects
Alignment
Where applicable, the following alignment in data presentation will be followed:
n
xx
Mean (SD)
xx.x (xx.xx)
Median
xx.x
Min, Max
xx, xx
n (%)
20 (100.0)
10 (50.0)
1   (5.0)


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TABLE, FIGURE, AND LISTING SHELLS
14
Clinical Study Report Tables and Figures 
Demographic Data
14.1.1.1.1
*Table* Template Disposition
Table 14.1.1 Subject Disposition (All Subjects)
50 mg CD388
150 mg CD388
450 mg CD388
Pooled 
Placebo
Overall
Subjects Screened (n)
xx
Subjects Randomized 
(Enrolled Population) 
(n)
xx
xx
xx
xx
xx
Subjects who Received 
Study Drug [n(%)]
xx (100.0)
xx (100.0)
xx (100.0)
xx (100.0)
xx (100.0)
Subject Completed the 
Study [n(%)]
Yes
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
No
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
If No, Reason(s) of 
Study Discontinuation 
[n(%)]
Reason 1
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Reason 2
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Etc.
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Subjects Included in 
Each Analysis 
Population [n(%)]
Safety 
Population
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Pharmacokinetic 
Population
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Note(s):
Percentages are based on the number of subjects who received at least one dose of study drug.
Safety population is defined as includes all subjects who receive any amount of study drug.


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Pharmacokinetic population is defined as all subjects who have received CD388 injection with at least 
1 dose and have at least one post-dose time point available.
Demographics
14.1.2.1.1
*Table* Template: Demographics
Table 14.1.2.1 Summary of Demographic and Baseline Characteristics (Safety Population)
  
  
50 mg CD388
(N=XX)
150 mg CD388
(N=XX)
450 mg CD388
(N=XX)
Pooled Placebo
(N=XX)
Overall
(N=XX)
Age (years)
n
xx
xx
xx
xx
xx
Mean (SD)
xx.x (xx.xx)
xx.x (xx.xx)
xx.x (xx.xx)
xx.x (xx.xx)
xx.x (xx.xx)
Median
xx.x
xx.x
xx.x
xx.x
xx.x
Min, Max
xx, xx
xx, xx
xx, xx
xx, xx
xx, xx
Sex [n(%)]
Male
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Female
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Ethnicity [n(%)]
Hispanic/Latino
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Not Hispanic/
Not Latino
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Race [n(%)]
Race1
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Race2
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Etc.
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Weight (kg) 
n
xx
xx
xx
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
Height (cm)
n
xx
xx
xx
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx
Min, Max
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
xx.x, xx.x
Body Mass Index 
(kg/m2)
n
xx
xx
xx
xx
xx
Mean (SD)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
xx.xx (xx.xxx)
Median
xx.xx
xx.xx
xx.xx
xx.xx
xx.xx


 
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Min, Max 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
  
  
 
 
 
 
 
 
 
 


 
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Table 14.1.2.2 Summary of Demographic and Baseline Characteristics (Pharmacokinetic Population) 
 
<Similar presentation as Table 14.1.2.1> 
 


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Pharmacokinetic, Pharmacodynamic, and Efficacy Data
Pharmacokinetic Data
14.2.1.1
Pharmacokinetic Concentration Summaries
Table 14.2.1.1.x Summary Statistics of CD388 Plasma Concentration Data Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population)
Analyte
Cohort
Dose
Nominal Time 
(h)
(mg)
0
2.00
4.00
X.XX
X.XX
X.XX
2856.00/3936.00
CD388
<COHORT>
<DOSE>
n
Mean
SD 
Min
Median
Max
CV (%)
Programming Note(s): 
x
Nominal Time to be presented with 2 decimals 
Numbering scheme:
x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3
Similar tables:
Table 14.2.1.2.x: Summary Statistics of CD388 Nasopharyngeal Concentration Data Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population)
Where, x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3


 
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Figure 14.2.1.1.x: Mean (+SD) Plasma Concentration-Time Profiles of CD388 Following Single Subcutaneous Administration 
of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population (Pharmacokinetic Population) 
 
 
Programming Note(s):  
x 
X and Y-axis will match the scaling of the data. 
x 
Linear and Semi-Log Scale will be provided 
 
Numbering scheme: 
x=1 for Linear scale and x=2 for semi-log scale 
 
Similar figures: 
Figure 14.2.1.1.x: Mean (+SD) Nasopharyngeal Concentration-Time Profiles of CD388 Following Single Subcutaneous 
Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population (Pharmacokinetic Population) 
Where, x=1 for Linear scale and x=2 for semi-log scale 
 
 


 
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14.2.1.2 Pharmacokinetic Parameter Summaries 
Table 14.2.1.2.1: Summary Statistics of Plasma PK Parameters of CD388 Following a Single Subcutaneous Administration 
of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population) 
PK Parameter 
Cohort 1 
(N=XX) 
Cohort 2 
(N=XX) 
Cohort 3 
(N=XX) 
Cmax (unit) 
 
 
 
n 
 
 
 
Mean (SD) 
 
 
 
Median (min,max) 
 
 
 
CV% 
 
 
 
Geometric mean (Geometric CV%) 
 
 
 
 
 
 
 
tmax (unit) 
 
 
 
n 
 
 
 
Median 
 
 
 
Min, Max 
 
 
 
 
 
 
 
…. (unit) 
 
 
 
n 
 
 
 
Mean (SD) 
 
 
 
Median (min,max) 
 
 
 
CV% 
 
 
 
Geometric mean (Geometric CV%) 
 
 
 
 
 
Programming Note(s):  
x 
All PK parameters noted in the SAP will appear in the table. 
 
Similar Tables: 
Table 14.2.1.2.2: Summary Statistics of Nasopharyngeal PK Parameters of CD388 Following a Single Subcutaneous 
Administration of CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population) 
 
 


 
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14.2.1.3 Statistical Analysis of Pharmacokinetic Data 
Table 14.2.1.3.1 Statistical Analysis for Dose Proportionality of AnalyteName Pharmacokinetic Parameters 
(Pharmacokinetic Population) 
 
   
 
 
 
95% CI of Slope 
 
Parameter (unit) 
n 
Intercept (α) 
Slope (β) 
Lower Bound 
Upper Bound 
R-squared 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cmax (unit) 
xx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
 
 
 
 
 
 
AUC0-inf (unit) 
xx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
 
 
 
 
 
 
AUC0-last (unit) 
xx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
 
 
 
 
 
 
Abbreviation(s):  CI = confidence interval. 
Note(s):  Proportionality analysis was performed using a power model: ln(PK parameter) = α + β • ln(Dose) + ε. 
 
 

 


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Safety Data
Adverse Events
14.3.1.1
Adverse Event Summary 
Table 14.3.1.1 Summary of Adverse Events (Safety Population)
  
50 mg CD388
(N=XX)
150 mg CD388
(N=XX)
450 mg CD388
(N=XX)
Pooled Placebo
(N=XX)
Number of AEs Reported (n)
xx
xx
xx
xx
Number of TEAEs Reported (n)
xx
xx
xx
xx
Subjects With at Least One TEAE [n(%)] [1]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Subjects With At Least One Drug-Related TEAE 
[n(%)] [1] [2]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
TEAEs by Relationship [3]
Related [n(%)] [2] 
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Unrelated [n(%)]  
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
TEAEs by Severity [3]
Mild [n(%)]  
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Moderate [n(%)]  
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Severe [n(%)]  
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Treatment-Emergent SAEs Reported (n)
xx
xx
xx
xx
Subjects With at Least One Treatment-Emergent 
SAE [n(%)][1]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Subject with at Least One Drug-Related 
Treatment-Emergent SAE [n(%)] [1] [2]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Subject with TEAE Leading to Discontinuation
[n(%)] [1]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Death [n(%)] [1]
xx (xx.x)
xx (xx.x)
xx (xx.x)
xx (xx.x)
Abbreviation(s): AE = adverse event; TEAE = treatment-emergent adverse event; SAE = serious adverse event.
[1] Percentages are based on the number of subjects in the Safety population in each treatment group.


 
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[2] TEAE that was reported as: “Definitely Related”, “Probably Related”, or “Possibly Related”. 
[3] Percentages are based on the number of TEAEs reported in each treatment group. 
 
 


 
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14.3.1.2 TEAE by SOC 
Table 14.3.1.2 Summary of Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety 
Population) 
 
  System Organ Class 
  MedDRA Preferred Term 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 Subjects with at least one 
TEAE [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  
 
 
 
 
 
 System Organ Class 1 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 11 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 12 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 13 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  
 
 
 
 
 
 System Organ Class 2 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 21 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 22 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 23 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
    
 
 
 
 
 
 Etc. 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Abbreviation(s):  MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment-emergent adverse event. 
Note(s): Each TEAE is counted only once for each subject within each System Organ Class and MedDRA Preferred Term. 
 
Programming Note(s):  
x 
SOC and PT are sorted alphabetically.  

 


 
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14.3.1.3 Drug-Related TEAE Summary by SOC and PT 
Table 14.3.1.3 Summary of Drug-Related Treatment-Emergent Adverse Events by System Organ Class and Preferred Term 
(Safety Population) 
 
  System Organ Class 
   MedDRA Preferred Term 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 Subjects With at Least One 
Drug-Related TEAE [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  
 
 
 
 
 
 System Organ Class 1 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 11 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 12 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 13 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  
 
 
 
 
 
 System Organ Class 2 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 21 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 22 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
   MedDRA Term 23 [n(%)] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
    
 
 
 
 
 
 Etc. 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Abbreviation(s): MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment-emergent adverse event. 
Note(s):  Each TEAE is counted only once for each subject within each System Organ Class and MedDRA Preferred Term. 
A drug-related TEAE is a TEAE that was reported as: “Definitely Related”, “Probably Related”, or “Possibly 
Related”.                                                                              
 
 
Programming Note(s):  
x 
SOC and PT are sorted alphabetically.  

 


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Listing of Deaths, Other Serious and Significant Adverse Events
Table 14.3.2.1 Listing of Death, Other Serious and Significant Adverse Events (Safety Population)
<Similar presentation as Listing 16.2.7.1>


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Safety Assessments
14.3.4.1
Out of Range Lab
Table 14.3.4.1.1 Listing of Out-of-Range Laboratory Values (Safety Population)
Category/
  Parameter   
(Unit)
Subject 
ID
Cohort/ 
Treatment
Visit 
Date/Time
Value
Reference 
Range
Reference 
Range 
Flag
Safety 
Review
Lab Category 1
  Lab Test 11
xxx
xxxxxx
xxxxxx
YYYY-MM-DD/HH:MM
xxx
xxx-xxx
Low
NCS
xxx
xxxxxx
xxxxxx
YYYY-MM-DD/HH:MM
xxx
xxx-xxx
High
CS
  Lab Test 12
  
Lab Category 2
Abbreviation(s): CS = clinically significant; NCS = not clinically significant; RPT = repeated; TBC = to be 
controlled.


 
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Table 14.3.4.1.2 Listing of Clinically Significant Laboratory Values 
 
<Similar presentation as Table 14.3.4.1.1> 
 
 


 
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14.3.4.2  Summary Lab 
Table 14.3.4.2.1.1 Summary of General Biochemistry (Safety Population)  
 
 
Parameter (Units) Visit 
  
 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
  
 
 
 
 
 
Albumin (g/dL) 
Baseline [1]  Value 
n 
xx 
xx 
xx 
xx 
 
 
  
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
  
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
  
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
  
 
 
 
 
 
 
Day 2 
 Value 
n 
xx 
xx 
xx 
xx 
 
 
  
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
  
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
  
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
  
 
 
 
 
 
 
 
 
Change from 
baseline 
n 
xx 
xx 
xx 
xx 
 
 
  
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
  
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
  
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
Etc. 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
Abbreviation(s): 
[1]  Baseline is defined as the last non-missing evaluation prior to the first dose of study drug. 
        
Programming Note(s):  
x 
Parameters are sorted alphabetically.  
 
 


 
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Table 14.3.4.2.2.1 Summary of Hematology (Safety Population) 
Table 14.3.4.2.3.1 Summary of Coagulation (Safety Population) 
Table 14.3.4.2.4.1 Summary of Urinalysis (Safety Population) 
Table 14.3.4.2.4.1 Summary of Lipids (Safety Population) 
 
<Similar presentation as Table 14.3.4.2.1.1> 
 
Table 14.3.4.2.2.2 Summary of Subjects with Potentially Clinically Significant General Biochemistry (Safety 
Population) 
Table 14.3.4.2.2.2 Summary of Subjects with Potentially Clinically Significant Hematology (Safety Population) 
Table 14.3.4.2.3.2 Summary of Subjects with Potentially Clinically Significant Coagulation (Safety Population) 
Table 14.3.4.2.4.2 Summary of Subjects with Potentially Clinically Significant Urinalysis (Safety Population) 
Table 14.3.4.2.5.2 Summary of Subjects with Potentially Clinically Significant Lipids (Safety Population) 
 
<Similar presentation as Table 14.3.5.3> 
 
 
 
 
 


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Vital Signs Data
14.3.5.1
Clinically Significant Vital Signs
Table 14.3.5.1 Listing of Clinically Significant Vital Signs Values
Parameter (Units)
Subject
ID
Cohort/ 
Treatment
Visit
Timepoint
Date/Time
Value
Safety 
Review
Vital Sign Test 1
xxx
CS
xxx
CS
Vital Sign Test 2
xxx
xxx
  Etc.
xxx
Abbreviation(s): CS = clinically significant; DBP = diastolic blood pressure; SBP = systolic blood pressure.


 
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14.3.5.2 Vital Signs Summary 
 
Table 14.3.5.2 Summary of Vital Signs (Safety Population)  
 
Parameter 
(Units) 
Visit 
Timepoint  
 
Drug A 10 mg 
(N=XX) 
Drug A 20 mg 
(N=XX) 
Etc 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
DBP (mmHg) 
Baseline [1]  
Value 
n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
Day 1 
1 h 
Value 
n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Change 
from 
baseline n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation(s):  DBP = diastolic blood pressure; SBP = systolic blood pressure. 
[1]  Baseline is defined as the last non-missing evaluation prior to the first dose of study drug. 
        


 
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Table 14.3.5.3 Summary of Subjects with Potentially Clinically Significant Vital Signs (Safety Population)  
 
Parameter 
(Units) 
PCS Criteria Visit 
Timepoint  
 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
DBP (mmHg) 
Baseline [1]  
Value 
n (%) 
xx (xx.xx) 
xx (xx.xx) 
xx (xx.xx) 
xx (xx.xx) 
 
 
 
 
 
 
 
 
 
 
Day 1 
1 h 
Value 
n (%) 
xx (xx.xx) 
xx (xx.xx) 
xx (xx.xx) 
xx (xx.xx) 
 
 
 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation(s):  DBP = diastolic blood pressure; SBP = systolic blood pressure. 
[1]  Baseline is defined as the last non-missing evaluation prior to the first dose of study drug. 
        
 
 


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Electrocardiogram Data
Table 14.3.6.1 Listing of Clinically Significant Electrocardiogram Assessments (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Visit
Timepoint
ECG #
Date/Time
Parameter 
Result
Safety 
Review 
xxxxx
xxxxxx
Screening
1
YYYY-MM-DD/
HH:MM
Interpretation
Abnormal
CS
Day 1
1 h 
3
YYYY-MM-DD/
HH:MM
Interpretation
Abnormal
CS
Abbreviation(s): CS = clinically significant.


 
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Page 31 of 53
14.3.6.1 ECG Summary 
Table 14.3.6.2 Summary of Electrocardiogram (Safety Population)  
 
Parameter 
(Units) 
Visit 
Timepoint  
 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
PR (msec) 
Baseline [1]  
Value 
n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
Day 1 
1 h 
Value 
n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Change 
from 
baseline n 
xx 
xx 
xx 
xx 
 
 
 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
 
 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation(s): 
[1]  Baseline is defined as the average of triplicates prior to the first dose of study drug. 
        

 


 
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Table 14.3.6.3 Summary of Electrocardiogram Outliers (Safety Population)  
Visit 
 Parameter 
Category 
50 mg CD388 
(N=XX) 
150 mg CD388 
(N=XX) 
450 mg CD388 
(N=XX) 
Pooled Placebo 
(N=XX) 
 
  
 
 
 
 
 
Baseline [1]  
QTcF 
Absolute Values 
n 
xx 
xx 
xx 
xx 
 
  
> 450 msec and ≤ 480 
msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
> 450 msec and ≤ 500 
msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
> 500 msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
 
 
 
 
 
Day 1 
 
QTcF 
Absolute Values 
n 
xx 
xx 
xx 
xx 
 
  
> 450 msec and ≤ 480 
msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
> 450 msec and ≤ 500 
msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
> 500 msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
 
 
 
 
 
 
 
QTcF 
Increases from 
Baseline 
n 
xx 
xx 
xx 
xx 
 
  
> 30 msec and ≤ 60 
msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
> 60 msec 
xx.x (xx.xx) xx.x (xx.xx) xx.x (xx.xx) 
xx.x (xx.xx) 
 
  
 
 
 
 
 
Etc. 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
Abbreviation(s): 
[1]  Baseline is defined as the average of triplicates prior to the first dose of study drug. 
 
 


Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29
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Other Safety Data
Table 14.3.7.1 Listing of Clinically Significant Physical Examination (Safety Population)
Body 
System
Subject 
ID
Cohort/ 
Treatment
Visit
Date/Time
Result 
Safety
Review 
Abnormal Finding
Abnormal
CS
Abbreviation(s): CS = clinically significant.


 
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Table 14.3.7.1 Summary of Reactogenicity/Injection-Site Inspection (Safety Population) 
<Similar presentation as Table 14.3.6.1> 
 
 


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16
Appendices
Randomization Scheme and Codes
Listing 16.1.7 Randomization (Safety Population)
Subject 
ID
Date
Randomization 
Number
Cohort
Treatment


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Subject Data Listings
Discontinued Subjects
Listing 16.2.1 Study Disposition (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Date of Completion or 
Discontinuation
Completion
Status
Reason for 
Discontinuation
If due to AE, specify AE #/
If due to death, specify date
Abbreviation(s): AE = adverse event.


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Protocol Deviations
Listing 16.2.2.1 Protocol Deviations (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Category
Date
Deviation 
Number
Deviation 
Code
Description
Severity
Listing 16.2.2.2 Major Protocol Deviations (Safety Population)
<Similar presentation as Listing 16.2.2.1>


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Subjects Excluded from the Analysis
Listing 16.2.3 Analysis Populations (Safety Population)
Subject ID
Cohort/ 
Treatment
Safety 
Population
Pharmacokinetic 
Population
Reason if Excluded from 
Pharmacokinetic Population


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Demographic Data
16.2.4.1
Demographic Characteristics
Listing 16.2.4.1 Demographic Characteristics (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Age
Sex
Ethnicity
Race
Other Race 
Weight (kg) Height (cm)
BMI (kg/m2)


 
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16.2.4.2 Medical History 
Listing 16.2.4.2 Medical History (Safety Population) 
 
Subject 
ID 
Cohort/ 
Treatment 
MH# 
System Organ Class 
MedDRA Preferred Term Description 
Start Date End Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation(s): MedDRA = Medical Dictionary for Regulatory Activities; MH = medical history. 
 
 

 


 
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16.2.4.3 Prior and Concomitant Medications 
Listing 16.2.4.3 Prior and Concomitant Medication (Safety Population) 
 
Subject 
ID 
Cohort/ 
Treatment 
CM
# 
Prior
Y/N 
Related 
to 
AE#/MH# 
ATC Level 1/ 
  Preferred Name/ 
    Medication Name Indication 
Dose 
(unit) Frequency Route 
Start 
Date 
End 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
Abbreviation(s):  AE = adverse event; ATC = Anatomical Therapeutic Chemical; CM = concomitant medication; MH = 
medical history. 
 

 


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Compliance and/or Drug Concentration Data
Listing 16.2.5 Investigational Product Administration (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Date/Time
Dose
Administered


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Individual Response Data
16.2.6.1
Pharmacokinetic Data
Table 16.2.6.1.x Individual CD388 Plasma Concentration Data Following a Single Subcutaneous Administration of <DOSE> 
mg CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population)
Analyte
Cohort
Dose
Subject 
ID
Nominal Time 
(h)
(mg)
0
2.00
4.00
X.XX
X.XX
X.XX
2856.00/3936.00
CD388
<COHORT>
<DOSE>
XX
XX
XX
Programming Note(s): 
x
Nominal Time to be presented with 2 decimals and will be based on cohort sampling
Numbering scheme:
x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3
Similar tables:
Table 16.2.6.2.x Individual CD388 Nasopharyngeal Concentration Data Following a Single Subcutaneous Administration 
of <DOSE> mg CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population)
Where, x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3


 
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16.2.6.1.1 
Individual PK Parameters 
Listing 16.2.6.1.x Individual Plasma PK Parameters of CD388 Following Single Subcutaneous Administration of CD388 to 
Healthy Japanese Adult Subjects(Pharmacokinetic Population) 
Subject ID 
Cmax (unit) 
tmax(unit) 
XXX 
XXX 
  
  
XXX 
XXX 
  
  
XXX 
XXX 
  
  
XXX 
XXX 
  
  
XXX 
XXX 
  
  
XXX 
XXX 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Programming Note(s):  
x 
All PK parameters noted in the SAP will appear in the listing. 
Similar Listings: 
Listing 16.2.6.2.x Individual Nasopharyngeal PK Parameters of CD388 Following Single Subcutaneous Administration of 
CD388 to Healthy Japanese Adult Subjects(Pharmacokinetic Population) 
 
 


 
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16.2.6.1.2 
PK Sampling Times 
Listing 16.2.6.1.3.1.x Actual Pharmacokinetic Plasma Sampling Times Following a Single Subcutaneous Administration 
of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
Analyte 
Cohort 
Dose 
(mg) 
Subject 
Nominal Time  
(unit) 
0 
2.00 4.00 X.XX X.XX X.XX 2856.00/3936.00 
<ANALYTE> 
<COHORT> <DOSE> <SUBJID> 
 
 
 
 
 
 
 
<SUBJID> 
 
 
 
 
 
 
 
<SUBJID> 
 
 
 
 
 
 
 
<SUBJID> 
 
 
 
 
 
 
 
…. 
 
 
 
 
 
 
 
 
Programming Note(s):  
Nominal Time to be presented with 2 decimals  
Numbering scheme: 
x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3  
Similar Listings: 
Listing 16.2.6.1.3.2.x Actual Pharmacokinetic Nasopharyngeal Sampling Times Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
Where, x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3 
 
Listing 16.2.6.1.3.3.x Deviations for Actual Pharmacokinetic Plasma Sampling Times Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
Where, x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3 
Listing 16.2.6.1.3.4.x Deviations for Actual Pharmacokinetic Nasopharyngeal Sampling Times Following a Single 
Subcutaneous Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
Where, x=1 for cohort 1, x=2 for cohort 2, x=3 for cohort 3 
 
 
 


 
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Figure 16.2.6.1.x.y Individual Plasma Concentration-Time Profiles of CD388 Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
 
Programming Note(s):  
x 
X and Y-axis will match the scaling of the data. 
x 
All subjects per Cohort will appear on this figure. 
x 
Linear and Semi-Log Scale will be provided 
 
Numbering scheme: 
x=1 for cohort 1, x=2 for cohort 2, upto x=3 for cohort 3 
y=1 for linear scale, y=2 for semi-log scale 
Similar Listings: 
Listing 16.2.6.2.x.y Individual Nasopharyngeal Concentration-Time Profiles of CD388 Following a Single Subcutaneous 
Administration of <DOSE> mg CD388 to Healthy Japanese Adult Subjects (Pharmacokinetic Population) 
Whwre,   
x=1 for cohort 1, x=2 for cohort 2, upto x=3 for cohort 3 
y=1 for linear scale, y=2 for semi-log scale 

 


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Adverse Event Listings
Listing 16.2.7.1 Adverse Events (Safety Population)
Subject
ID
Cohort/ 
Treatment
AE#/ 
TEAE?
SOC/
PT/
  Description
  of AE
Study Day 
of Onset
Resolution 
Date/Time
(Duration)
I:Maximal
  Severity
R:Causality
  Assessment
E:Expectedness
O:Outcome
S:Serious AE
D:AE leading to 
Discontinuation
A: Action Taken with
   Study Treatment
OA:Other Action(s)
   Taken
C: Concomitant Given
Abbreviation(s): AE = adverse event; PT = preferred term; SOC = system organ class; TEAE = treatment-emergent adverse 
event.


Protocol No. CD388.SQ.1.03 | Altasciences Project No. CID-P2-387 | Version 1.0 | 2023/06/29
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Listing of Individual Laboratory Measurements by Subject 
Listing 16.2.8.1 General Biochemistry (Safety Population)
Subject 
ID
Cohort/ 
Treatment
Parameter 
(Units)
Reference 
Range
Visit 
Date/Time
Value
Reference 
Range Flag
Safety 
Review
xxxxx
xxxxxx
Day -1 [1]
Abbreviation(s): CS = clinically significant; PCS = potentially clinically significant; RPT = repeated; TBC = to 
be controlled.
[1] Baseline is defined as the last non-missing evaluation prior to the first dose of study drug.
Programming Note(s):
x
Add [1] (or proper number) to indicate baseline in Visit.


 
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Listing 16.2.8.2 Hematology (Safety Population) 
Listing 16.2.8.3 Serology (Safety Population) 
Listing 16.2.8.4 Urine Drug Screen (Safety Population) 
Listing 16.2.8.5 Urinalysis (Safety Population) 
Listing 16.2.8.6 Other Laboratory Tests (Endocrinology) (Safety Population) 
 
<Similar presentation as Listing 16.2.8.1 (to update per protocol definition)> 
 
 
 


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Listing of Other Individual Measurements by Subject 
16.2.9.1
Vital Signs
Listing 16.2.9.1 Vital Signs (Safety Population)
Subject
ID
Cohort/ 
Treatment
Visit
Timepoint
Date/Time
Parameter 
(Units)
Value
Safety
Review 
xxxxx
xxxxxx
Day 1
Predose [1]
Abbreviation(s): CS = clinically significant; PCS = potentially clinically significant; NCS = not clinically 
significant.
[1]
Baseline is defined as the last non-missing evaluation prior to the first dose of study drug.
Programming Note(s): 
x
Add [1] (or proper number) to indicate baseline in Timepoint.


 
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Listing 16.2.8.7 Reactogenicity/Injection Site Inspection (Safety Population) 
<Similar presentation as Listing 16.2.9.1 > 
 


 
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16.2.9.2 ECG 
Listing 16.2.9.2 Electrocardiogram Assessments (Safety Population) 
 
Subject 
ID 
Cohort/ 
Treatment 
Visit 
Timepoint ECG # 
Date/Time 
Parameter (Unit) 
Value 
Safety 
Review  
 
 
 
 
 
 
 
 
 
 
 
xxxxx 
xxxxxx 
Screening  
1 
YYYY-MM-DD/ 
HH:MM 
ECG Parameter 1 
xx.x 
 
 
 
 
 
 
 
 
ECG Parameter 2 
xx.x 
 
 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
Interpretation 
 
Abnormal NCS  
 
 
 
 
2 
 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
Average 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 1 
Predose 
1 
YYYY-MM-DD/ 
HH:MM 
ECG Parameter 1 
xx.x 
 
 
 
 
 
 
 
 
ECG Parameter 2 
xx.x 
 
 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
Interpretation 
 
Abnormal NCS  
 
 
 
 
2 
 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
Average [1] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Abbreviation(s):  CS = clinically significant; NCS = not clinically significant. 
[1] Baseline is defined as the average of triplicates prior to the first dose of study drug. 
 
Programming Note(s):  
x 
Add [1] (or proper number) to indicate baseline;  
x 
Column of “ECG #” could be removed if only one assessment at a timepoint; 
x 
Safety review only applicable to Interpretation row.  
 
 


 
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Page 53 of 53
16.2.9.3 Physical Examination 
Listing 16.2.9.3 General Physical Examination (Safety Population) 
 
Subject 
ID 
Cohort/ 
Treatment 
Visit 
Date/Time 
Body System 
Result  
Safety 
Review  
Abnormal Finding 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Abbreviation(s):  CS = clinically significant; NCS = not clinically significant. 
 
 
 
 


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