Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 77
Healthy volunteers: yes

Brief summary:
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin.

Detailed description:
A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat single-dose, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.

Arms:
arm 1: Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection arm 2: Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection arm 3: Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection arm 4: Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection arm 5: Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 6: Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 7: Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 8: Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 9: High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 10: High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 11: High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 12: High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose arm 13: Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection arm 14: Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ 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 document:
Prot_000.pdf: 
Study Protocol 
 
 
Title: 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single 
Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and 
Pharmacokinetics of CD388 Intramuscular or Subcutaneous 
Administration in Healthy Subjects 
NCT Number: 
NCT05285137 
Document Date: 
07 FEB 2023 
 


Cidara Therapeutics, Inc. 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential 
Page 1 of 85 
PROTOCOL TITLE PAGE 
Title 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single 
Dose, Dose-Escalation Study to Determine the Safety, Tolerability, 
and Pharmacokinetics of CD388 Intramuscular or Subcutaneous 
Administration in Healthy Subjects 
Study Drug 
CD388 Injection 
Original Protocol 
05DEC2021 
Amendment 1 
28JAN2022 
Amendment 2 
07FEB2023 
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 
Monica Sanford 
Cidara Therapeutics, Inc. 
6310 Nancy Ridge Drive, Suite 101 
San Diego, California 92121, USA 
Office: +1.858.283.8867 
Mobile: +1.860.405.7697 
Email: msanford@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.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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PROTOCOL APPROVAL PAGE 
Protocol: CD388.IM.SQ.1.01 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, 
Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics 
of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects 
 
Original Protocol:  05DEC2021 
 
Amendment 1:  28JAN2022 
 
Amendment 2: 07FEB2023 
 
SPONSOR SIGNATURE 
 
 
 
Signature 
Taylor Sandison, MD, MPH 
Chief Medical Officer, 
Cidara Therapeutics, Inc. 
 
Date 
 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 3 of 85 
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-Dose and Repeat Single-Dose, Dose-Escalation 
Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous 
Administration in Healthy 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 
 
• To determine the safety and tolerability 
profile of CD388 Injection when dosed either 
by intramuscular (IM) or subcutaneous (SQ) 
administration as a single dose to healthy 
adult subjects. 
• 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 
 
• To determine the plasma pharmacokinetic 
(PK) profile of CD388 Injection when dosed 
either by IM or SQ administration following 
a single dose and a repeated single dose to 
healthy adult subjects. 
• 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-t), area under 
the plasma concentration-time curve from time 
0 extrapolated to infinity (AUC0-∞). 
• To determine the safety and tolerability 
profile of CD388 Injection when dosed either 
by IM or SQ administration as a repeated 
single dose (after washout of 3 months 
or 5 effective half-lives from the first dose; 
whichever is longer) to healthy adult subjects. 
• Incidence and severity of TEAEs, including but not 
limited to AEs and SAEs (including systemic 
reactogenicity/injection site reactions and 
hypersensitivity reactions), AEs leading to study 
drug discontinuation and/or study withdrawal, 
vital signs, ECGs, and clinical laboratory tests 
(including hematology, coagulation, serum 
chemistry, and urinalysis), after a repeated single 
dose of CD388. 
 
 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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Objectives 
Endpoints 
Exploratory 
• To determine the PK profile of CD388 
Injection in upper respiratory tract after IM 
or SQ administration as a single dose to 
healthy adult subjects. 
• 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-t). 
• To identify CD388 metabolites in plasma, 
CD388 and its metabolites in urine, 
and CD388 drug-antibody ratio (DAR) 
distribution in plasma, and CD388 
glycoforms in serum after IM or SQ 
administration to healthy adult subjects. 
• CD388 metabolites (e.g., free zanamivir, zanamivir 
dimers) in plasma and urine, CD388 in urine 
and nasal wash, CD388 DAR distribution in 
plasma, and CD388 glycoforms in serum, to be 
reported separately. 
• To evaluate biomarkers that may be 
associated with AEs after CD388 Injection. 
• Results of the analyses of exploratory biomarkers 
(including but not limited to cytokines, 
chemokines, acute phase reactants, etc.). 
• To evaluate CD388 immunogenicity. 
• Anti-drug antibody titers in blood (plasma or 
serum). 
• To explore pharmacogenomics related to 
CD388. 
• Results of the analyses of pharmacogenomic 
samples, to be reported separately. 
• To explore the effects on cardiac safety in 
subjects administered CD388 Injection. 
• 12-lead ECG and Holter monitoring parameters. 
• To explore the effect of CD388 Injection on 
the occurrence of influenza-like illness 
(during flu season). 
• Influenza-like illness reporting during the 
outpatient follow-up period. 
  
Study Design: This is a first-in-human (FIH), Phase 1, single-center, prospective, randomized, double-blind 
study of ascending single doses of CD388 Injection administered IM or SQ to healthy adult subjects followed by 
another single dose of CD388 Injection administered by the same route 3 months or 5 effective half-lives, 
whichever is longer, after the first dose in the middle and high dose groups (dosing may be adjusted for 
tolerability). The goals are to assess safety, tolerability, immunogenicity (anti-drug antibodies [ADA]), and PK 
of CD388.  
Dose levels of CD388 to be assessed will follow an ascending single dose design with the starting dose based on 
findings from 3-month rat and monkey toxicology studies. Within each route (IM and SQ dose, route assignment 
is unblinded), subjects will be randomized to receive a single dose of CD388 Injection or saline placebo 
(treatment assignment is blinded) according to the design in the table below. It should be noted that each cohort 
will be divided into 2 groups identified as “sentinel” groups (randomized 1:1) and “main” groups (randomized 
7:2):  
• Low dose (50 mg) level: Cohort 1A (IM) and Cohort 1B (SQ) – each route n = 2 sentinel and n = 9 main 
• Mid dose (150 mg) level: Cohort 2A (IM) and Cohort 2B (SQ) – each route n = 2 sentinel and n = 9 main 
• High dose (450 mg) level: Cohort 3A (IM) and Cohort 3B (SQ) – each route n = 2 sentinel and n = 9 main 
• Highest dose (900 mg) level: Cohort 4B (SQ) – n = 2 sentinel and n = 9 main 
For each route, the sentinel or first group of 2 subjects (1 CD388: 1 placebo) at a dose level will be administered 
blinded study drug and closely monitored for safety for at least 1 week. The Principal Investigator (PI) 


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and Sponsor will review blinded safety data after the initial sentinel group subjects at a dose level have completed 
dosing and followed for a minimum of 1 week. If no drug-related SAEs or drug-related Grade ≥3 AEs have 
occurred, the subjects in the corresponding main group may be dosed within 24 hours. The observation duration 
may be adjusted for the sentinel groups in Cohorts 2A, 2B, 3A, 3B, and 4B based on data from previous cohorts. 
After all subjects at a dose level (for the IM cohorts and SQ cohorts separately) have completed study drug 
administration and have undergone protocol-specified procedures and assessments for ≥14 days, the PI 
and Sponsor will review blinded safety data, including AEs (including reactogenicity/injection site reactions 
and hypersensitivity reactions), vital signs, 12-lead ECGs, and clinical laboratory results (including hematology, 
coagulation, serum chemistry, and urinalysis) to determine the safety and tolerability of the study drug. 
The incidence and severity of AEs, and adverse changes in vital signs, clinical laboratory findings, and ECGs 
will be taken into consideration when determining safety and tolerability of study drug. Escalation between dose 
levels will be based on review of at least 14-day post-dose safety data. If the dose/route of administration is 
determined to be safe and well tolerated ≥14 days after dosing, the next cohort of subjects will be enrolled 
and randomized to receive the next higher dose level of CD388 Injection or placebo. The data cut-off time point 
for data review and dose escalation decision has been adjusted for Cohorts 2A, 2B, 3A, and 3B based on data 
from Cohorts 1A and 1B.  
Study Design 
Dose (mg) 
Number of Subjects (N = 77) 
Intramuscular (IM) 
Subcutaneous (SQ) 
Cohort 
CD388 
(n = 24) 
Placebo 
(n = 9) 
Cohort 
CD388 
(n = 32) 
Placebo 
(n = 12) 
50 
Cohort 1A (sentinel) 
1 
1 
Cohort 1B (sentinel) 
1 
1 
50 
Cohort 1A (main) 
7 
2 
Cohort 1B (main) 
7 
2 
150 
Cohort 2A (sentinel) 
1 
1 
Cohort 2B (sentinel) 
1 
1 
150 
Cohort 2A (main) 
7 
2 
Cohort 2B (main) 
7 
2 
450 
Cohort 3A (sentinel) 
1 
1 
Cohort 3B (sentinel) 
1 
1 
450 
Cohort 3A (main) 
7 
2 
Cohort 3B (main) 
7 
2 
900 
NA 
NA 
NA 
Cohort 4B (sentinel) 
1 
1 
900 
NA 
NA 
NA 
Cohort 4B (main) 
7 
2 
Abbreviation: NA = not applicable. 
Note: Immediately prior to the second single dose, within each dose and route, any dropouts in the sentinel groups will be 
randomly replaced with subjects from the main groups, retaining their original treatment assignment (i.e., subjects 
assigned to placebo will remain placebo, and subjects assigned to CD388 will remain CD388). 
Subjects in Cohorts 1A, 1B, and 4B will receive a single dose of CD388 or placebo. 
Subjects in Cohorts 2A and 2B and Cohorts 3A and 3B will receive a second single dose of CD388 Injection 
or placebo after washout of 3 months or 5 effective half-lives, whichever is longer, after the first dose if it is 
determined that the safety and tolerability of the first dose is acceptable upon review of the cumulative safety 
data. Immediately prior to the second single dose, within each dose and route, any dropouts in the sentinel groups 
will be randomly replaced with subjects from the main groups, retaining their original treatment assignment 
(i.e., subjects assigned to placebo will remain placebo, and subjects assigned to CD388 will remain CD388; this 
may require unblinded personnel to oversee).  
The PI and Sponsor will review blinded safety data after the initial sentinel group subjects at a dose level have 
completed dosing and followed for the minimum observation period as determined during the first single dose. If 
no drug-related SAEs or drug related Grade ≥3 AEs have occurred, the subjects in the corresponding main group 
may be dosed within 24 hours.  
The dose escalation scheme is presented in Section 1.2. 


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Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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The Schedule of Events is presented in Table 1 (first single dose, Cohorts 1A, 1B, 2A, 2B, 3A, 3B), Table 2 
(second single dose, Cohorts 2A, 2B, 3A, 3B), and Table 3 (single dose, Cohort 4B). All subjects will be 
admitted to the clinical research unit (CRU) for observation and safety assessments from Day -1 (check-in) 
to Day 30.  
Subjects will be monitored for AEs (including reactogenicity/injection site reactions and hypersensitivity 
reactions) and SAEs as indicated below: 
Cohort 
AE/SAE monitoring period from signing of ICF: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
Abbreviation: ICF = informed consent form. 
Safety will also be assessed by physical examinations, ECGs, vital signs measurements, and laboratory 
evaluations (hematology, coagulation, serum chemistry, and urinalysis) at various time points during and after the 
CRU stay. Concomitant medication use will be recorded throughout the study. 
Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor as indicated 
below: 
Cohort 
Holter Monitoring Period 
1A, 1B 
1 hour before administration of study drug until 48 hours after dosing 
2A, 2B, 3B 
1 hour before first administration of study drug until 48 hours after dosing a 
3A 
Predose from 1 hour before administration of first single dose until 
administration is complete, and from 72 to 120 hours after dosing a 
4B 
Predose from 1 hour before administration of single dose until administration 
is complete, and from 72 to 120 hours after dosing
Note: Timing of ECG monitoring has been adjusted for Cohort 3A and 4B based on PK and ECG data. 
a. Performed at the second administration period only if required to further evaluate observations from
prior peri-dosing period (at the discretion of the Investigator).
Blood PK samples, and blood samples to assess ADA will be collected from all subjects for the purpose of 
maintaining the blind, but only samples from the CD388 Injection group will be analyzed (using validated assays) 
by an unblinded central bioanalytical laboratory. After discharge from the CRU, additional sample collection for 
PK and ADA will be performed at specified time points after dosing. The timing of PK sampling has been 
adjusted for Cohorts 2A, 2B, 3A, and 3B based on data from previous cohorts. 
Additional blood samples will be collected for pharmacogenomics and exploratory biomarker evaluation, 
and additional blood and urine samples will be collected for exploratory metabolite identification, to be reported 
separately. Plasma samples collected for PK analysis may also be used for CD388 drug-antibody ratio (DAR) 
distribution and metabolite identification after completion of PK analysis. Nasopharyngeal swabs will also be 
collected for CD388 exploratory assays. Nasal wash collection will occur during the second single dose at the 
time of Cmax as determined from the first single dose. Nasal wash collection for Cohort 4B will occur during 
dosing on Day 7. 
Number of Subjects 
Up to 77 subjects will be enrolled in this study, with approximately 56 of these subjects expected to receive 
CD388 Injection. 
Inclusion Criteria  
Subjects must meet the following inclusion criteria: 
1.
Willing and able to provide written informed consent.
2.
Males and females 18 to 65 years of age, inclusive.
3.
A female subject must meet one of the following criteria:


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Protocol CD388.IM.SQ.1.01 
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Amendment 2 
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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 205 days 
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) or in a menopausal state (at least 
1 year without menses), as confirmed by follicle-stimulating hormone (FSH) levels (≥40 mIU/mL). 
4. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test 
(β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the 
first dose of study drug. 
5. 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 to not donate sperm during the study and until 
at least 205 days after the last dose of the study medication. 
6. Good health and without signs or symptoms of current illness. 
7. 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) ≥80 mL/min as calculated using the Cockcroft-Gault equation: 
𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶= 
(140 −𝑎𝑎𝑎𝑎𝑎𝑎) × (𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 𝑖𝑖𝑖𝑖 𝑘𝑘𝑘𝑘)
72 × (𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 𝑖𝑖𝑖𝑖 𝑚𝑚𝑚𝑚/𝑑𝑑𝑑𝑑) × (0.85 𝑖𝑖𝑖𝑖 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓) 
d. Negative urine screen for drugs of abuse and alcohol at screening and Day -1. 
8. Body mass index (BMI; weight in kg divided by height in m squared) between 18.0 and 32.0 kg/m2, 
inclusive. 
9. 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. 
10. 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. 
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. 
Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN]) 


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b. Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN) 
c. 
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 (≥1.25 × ULN) 
d. Total bilirubin, Grade ≥1 (≥1.1 × ULN) 
e. 
Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, 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 check-in to the CRU. 
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 screening or CRU check-in for severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) by polymerase chain reaction (PCR). Beginning with Protocol Amendment 2, antigen 
testing may be used if PCR is not available. 
8. Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 
(COVID-19).* 
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. 
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 when participating in non-interventional clinical trials 
within 60 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. Previous participation in another study within 
30 days 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. The PI considers that the volunteer should not participate in the study. 
* 
Full COVID-19 vaccination prior to participation is strongly recommended. 
** In the event a subject chooses to receive one of the two 2-dose approved or emergency-use-authorized 
COVID-19 vaccines (Comirnaty® [Pfizer], Spikevax™ [Moderna]) in the interval between two CRU stays 
(Cohort 2A/2B or Cohort 3A/3B), flexibility in timing of the second CRU stay should be applied, to allow 
appropriate receipt of the second vaccine dosage or booster (based on the respective vaccine label) + 14 days, 
to minimize risk of confounding findings/observations. 
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 either intramuscular (IM) or subcutaneous (SQ) injection at the dose 
described in Table 5, depending upon the subject’s randomization assignment. 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 IM or SQ as the placebo control. 


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Duration of Treatment 
A single dose of study drug will be administered IM or SQ on Day 1. Study participation will require up to 
28 days for screening procedures, and ~120 days for the first single dose (check-in to the CRU on Day -1; CRU 
inpatient stay for study drug administration, observation, and assessments and procedures for 31 days [Days -1 
to Day 30]; and 4 CRU outpatient visits for additional assessments and procedures). 
Subjects in Cohorts 2A, 2B, 3A, and 3B who receive a second single dose will have an additional 168 days of 
participation, with similar study visits to that of the first administration. 
Criteria for Evaluation 
Safety and Tolerability of Study Drug 
Safety and tolerability will be assessed by monitoring AEs (including reactogenicity/injection site reactions, 
hypersensitivity reactions, and adverse events of special interest [AESIs]), vital signs, 12-lead ECGs, Holter 
monitoring, clinical laboratory results (including hematology, coagulation, serum chemistry, and urinalysis), 
and concomitant medication usage throughout the study.  
See the Study Design section for details regarding dose level/cohort 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. 
If any subject develops a Grade ≥2 AE 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 and route 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 the first 
and second single doses of the study drug. Blood samples collected for PK analysis may also be used for 
metabolite identification after completion of PK analysis, along with urine samples. Plasma samples, 
nasopharyngeal swabs, and nasal washes will be analyzed for the concentration of CD388. Anti-drug antibodies 
(ADA) will also be measured at selected time points by a validated ELISA method. 
Pharmacogenomics 
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 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. They may also be used to develop 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 (such as but not limited to RNA 
or proteins) on the assumption that these markers may 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. 
They may also be used to develop 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. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 10 of 85 
Withdrawal from Study  
Subjects may be withdrawn from the study for any of the following reasons: 
• 
Subject is unable or unwilling to continue 
• 
Subject elects to withdraw informed consent 
• 
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 
• 
Protocol non-compliance 
• 
Subject lost to follow-up, or follow-up is not possible 
• 
The Investigator considers that it is in the subject’s best interest not to continue participation in the study 
Subject Stopping Rules 
Additionally, subjects in Cohorts 2A, 2B, 3A, and 3B will be followed through Outpatient Visit 4 (OV4) of the 
first dosing period, and will not receive the second single dose: 
• 
If the subject develops anaphylaxis or a related Grade 3 or Grade 4 AE 
• 
If the subject has a persistent (i.e., >5 days with no response to treatment) Grade ≥2 rash considered 
related to the investigational drug by the Principal Investigator (Appendix 4) 
• 
If the Investigator believes that it is in the best interest of the subject to not receive a second dose. 
• 
If the subject no longer meets all eligibility criteria prior to the second single dose 
• 
If the subject becomes pregnant prior to the second single dose 
If a subject is removed from the study for any reason, the subject will be followed for resolution of any ongoing 
AE(s). 
Temporary Study Halt for Safety Review 
The study will be temporarily halted, pending review of available data, if any of the following occur:  
• 
If ≥2 subjects experience the same Grade 3 AE event or laboratory abnormality within 28 days after 
study drug administration, considered attributable to CD388 or cannot be attributed to another cause 
(Investigator to consider the potential of IM injections to cause significant transient increases of creatine 
kinase [CK], when evaluating the potential relatedness of this laboratory abnormality to the 
investigational drug. A transient CK increase after IM injection is to be considered “not related” to the 
study drug.) 
• 
If ≥1 subject experiences a Grade 4 AE or laboratory abnormality 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, a substantial amendment 
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, PK, and pharmacodynamics will be summarized using descriptive statistics. There will be no formal 
hypothesis testing. Analysis populations are: 
• 
Safety Population: all subjects who receive any amount of study drug 
• 
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, route (IM or SQ), and study drug (CD388 Injection or placebo). Listings 
of individual subject data will also be produced. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 11 of 85 
Safety will be evaluated by presenting summaries of AEs and SAEs, ECGs, clinical laboratory evaluations 
(hematology, coagulation, serum chemistry, and 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, severity, and route 
of administration.   
Treatment-emergent adverse events are defined as follows: 
Cohort 
TEAE is an AE that occurs during or after study drug administration: 
1A, 1B 
Through 4 months after the dose of study drug  
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
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. The TEAEs occurring after the first single dose and after the second 
single dose will be analyzed separately. 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 PK parameters that will be assessed in the PK Analysis Population include: 
• 
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-t) 
• 
area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)  
CD388 concentration in the upper respiratory tract as determined from nasopharyngeal (NP) swabs collection 
will be summarized and reported separately. 
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. 
Metabolite identification and profiling, CD388 in urine and nasal wash, CD388 DAR distribution, CD388 
glycoforms, pharmacogenomics, and exploratory biomarkers will be reported separately. 
Two blinded interim analyses of selected safety and PK data, one for the first dose level and another one for the 
second dose level, are planned for internal decision making or health authority interaction. 
 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 12 of 85 
1.1. 
Schedule of Events 
1.1.1. 
First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B 
Table 1: 
Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B 
 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
Day 
(Window) 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion criteria c 
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) 
 
X 
X d 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Safety ECG e 
X 
X 
X 
 
 
X 
 
 
 
 
X 
 
 
 
X 
Holter Monitor ECG f 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
X 
 
X 
X g 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Lipids, coagulation, complement 
activation h 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (HBV, HCV, HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (SARS-CoV-2) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum/urine pregnancy test, FSH i 
X 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
Drug/alcohol screen j 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dosing of study drug 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Reactogenicity/injection site inspection k 
 
 
X  
X  
X 
 
 
 
 
 
 
 
 
 
 
PK sample collection l 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite identification 
and CD388 DAR distribution m 
 
 
X 
X 
 
 
 
 
X 
 
X 
 
 
X 
 
Samples for CD388 glycoforms n 
 
 
predose 
X 
 
X 
 
 
X 
X 
X 
X 
 
X 
 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 13 of 85 
 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
Day 
(Window) 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Pharmacogenomics blood sample o 
 
 
predose 
 
 
 
 
 
 
 
 
 
 
 
 
Exploratory biomarker samples 
 
 
predose 
 
X g 
 
 
 
 
 
 
 
 
 
 
Anti-drug antibodies 
 
 
predose 
 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
Nasopharyngeal swab collection p 
 
 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Assess and record AEs q 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/procedures 
review r 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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; OV = outpatient visit; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe 
acute respiratory syndrome coronavirus 2. 
Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B 
a. For subjects in Cohorts 1A and 1B: outpatient visits will occur at Day 45 (OV1), Day 60 (OV2), Day 90 (OV3), and Day 120 (OV4).  
For subjects in Cohorts 2A, 2B, 3A, and 3B, timing of outpatient visits will occur at Day 45 (OV1), ~2× t½ (OV2), ~3× t½ (OV3), and ~4× t½ (OV4), pending 
PK data from Cohorts 1A and 1B. If 2 half-lives have passed by OV2, the visit may be omitted. 
b. For subjects who discontinue study early, the OV4 procedures should be performed. 
c. For subjects in Cohorts 2A, 2B, 3A, and 3B, reconfirmation of inclusion and exclusion criteria (retesting of FSH not required) is to be completed at second 
single dose period’s CRU check-in and prior to the second single dose of CD388 Injection or placebo.  
d. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated.  
e. 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 and semi-recumbent when ECG is being conducted. 
f. For Cohorts 1A, 1B, 2A, 2B, 3B: Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG 
tracings, including all 12-leads and of 10 seconds duration, will be extracted in triplicate for 5-minute observation periods at 60, 45, and 30 minutes predose; 
and at 2, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours postdose (expected time to maximum concentration is 1 to 2 days after administration). The Holter monitor 
will be removed on Day 3. The Holter monitor may be removed once on Day 2 for up to 15 minutes for shower/bathing, at least 2 hours away from the next 
ECG timepoint (i.e., 30, 36, or 48 hours postdose). 
For Cohort 3A: Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG tracings, 
including all 12 leads and of 10 seconds duration, will be extracted in triplicate at prespecified time points for a 5-minute observation period starting from 
1 hour before dosing, then at 72, 76, 80, 84, 96, 102, 106, 110, 118, and 120 hours after administration of study drug, and stored in a digital format. The 
Holter monitor may be removed once on Day 5 for up to 15 minutes for shower/bathing, at least 1 hour away from the next ECG timepoint. The Holter 
monitor will be removed on Day 6. 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 14 of 85 
Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B (continued) 
g. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
h. 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). 
i. A sensitive serum pregnancy test (β‑human chorionic gonadotropin) is required at screening and OV4 for females of childbearing potential. 
FSH (if applicable to confirm postmenopausal status) is only required once. Urine pregnancy test may be performed at all other time points. 
j. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see Appendix 2). 
k. 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), with any abnormal findings reported as AE s. Reactions will be rated according to the scale provided in 
Table 7. 
l. For Cohorts 1A, 1B, 2A, 2B, 3B: 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 Days 7, 9, 11, 14, 21, 30 
(each ±2 hour window). Postdose samples collected at outpatient CRU visits at OV1, OV2, OV3, and OV4 have the same windows (i.e., in ±days) as the 
visits.  
For Cohort 3A: Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 12 and 24 hours (±30 minute window); 48 hours 
(±1 hour window); 72, 84, 96, 108, 120 hours (each ±2 hour window); and Days 7, 9, 11, 14, 21, 30 (each ±2 hour window). Postdose samples collected at 
outpatient CRU visits at OV1, OV2, OV3, and OV4 have the same windows as the visits.  
m. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) and CD388 DAR distribution will be collected on Day 1 at 2 hours 
postdose, on Day 2 at 24 hours postdose, on Days 14 and 30, and at OV3. Urine samples for metabolite identification will be collected on Day 1 from 
0– 12 hours and from 12–24 hours postdose, on Day 2 from 24–48 hours postdose, on Day 14 over a 24-hour period, and over a 24-hour period that starts on 
Day 29 and ends prior to CRU check-out on Day 30. 
n. Serum samples for CD388 glycoforms will be collected predose on Day 1 and once in the morning on Days 2, 7, 14, 21, and 30, and at the OV1 and OV3 
visits. 
o. 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. 
p. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. 
q. 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 4 months after the last dose of study drug, whichever is longer. 
r. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit.  
 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 15 of 85 
1.1.2. 
Second Single Dose, Cohorts 2A, 2B, 3A, and 3B 
Table 2: 
Schedule of Events: Second Single Dose, Cohorts 2A, 2B, 3A, and 3B 
 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
Day 
(Window) 
-1 
(±10) 
1 
2 
3-6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Inclusion/Exclusion criteria c 
X 
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) 
 
X d 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Safety ECG e 
X 
X 
 
 
X 
 
 
 
 
X 
 
 
 
X 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
 
X 
X f 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Virology screening (HBV, HCV, HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (SARS-CoV-2) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy g 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drug/alcohol screen h 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dosing of Study Drug 
(Cohorts 2 and 3 only) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Reactogenicity/injection site inspection i 
 
X  
X  
X 
 
 
 
 
 
 
 
 
 
 
PK sample collection j 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite identification k 
 
X 
X 
 
 
 
 
X 
 
X 
 
 
X 
 
Exploratory biomarker samples 
 
predose 
 
X f 
 
 
 
 
 
 
 
 
 
 
Anti-drug antibodies 
 
predose 
 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
Nasopharyngeal swab/nasal wash 
collection l 
 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Assess and record AEs m 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/procedures 
review n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AEs = adverse events; BMI = body mass index; BP = blood pressure, CBC = complete blood count; COVID-19 = coronavirus disease 2019; CRU = clinical 
research unit; ECG = electrocardiogram; 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. 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 16 of 85 
Schedule of Events: Second Single Dose, Cohorts 2A, 2B, 3A, and 3B 
a. For subjects in Cohorts 2A, 2B, 3A, and 3B: outpatient visits will occur at Day 45 (OV1), Day 84 (OV2), Day 126 (OV3), and Day 168 (OV4). 
b. For subjects who discontinue study early, the Day 168 procedures should be performed. 
c. Reconfirmation of inclusion and exclusion criteria (retesting of FSH not required) is to be completed at CRU check-in on Day -1 and prior to the second 
single dose of CD388 Injection or placebo on Day 1. 
d. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated.  
e. 12-lead ECG is to be performed at CRU check-in on Day -1, predose (immediately prior to study drug administration on Day 1) and 6 hours postdose 
(±10 minutes), and as indicated in the Schedule. Subjects are to be resting and semi-recumbent when ECG is being conducted. 
f. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
g. Urine pregnancy test is required for females of childbearing potential at CRU check-in on Day -1. 
h. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see Appendix 2). 
i. 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), with any abnormal findings reported as AEs. Reactions will be rated according to the scale provided in 
Table 7. 
j. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 24 hours (±30 minute window); 48 hours (±1 hour window); 72, 96, 
120, 144, 168 hours (each ±2 hour window); and Days 9, 10, 11, 12, 14, 21, 30 (each ±2 hour window). Postdose samples collected at outpatient CRU visits 
on Days 45, 60, 90, and 120 have the same windows (i.e., in ±days) as the visits.  
k. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) will be collected on Day 1 at 2 hours postdose, on Day 2 at 24 hours 
postdose, on Day 30, and on Day 90. Urine samples for metabolite identification will be collected on Day 1 from 0–48 hours, from 48–96 hours, and from 
96–144 hours postdose, on Day 14 over a 24-hour period, and over a 24-hour period that starts on Day 29 and ends prior to CRU check-out on Day 30. 
l. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. Nasal wash collection will occur at the time of 
Cmax as determined from the first single dose (approximately 144 hours after dosing). 
m. Adverse events (including influenza-like illness which will be tested for both COVID-19 and flu) will be collected for all subjects as indicated below: 
Cohort 
AE/SAE monitoring period from signing of Informed Consent Form: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
Note: the final AE assessment will be conducted via a follow-up phone call to the subject. 
n. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit. 
 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 17 of 85 
1.1.3. 
Single Dose, Cohort 4B 
Table 3: 
Schedule of Events: Single Dose, Cohort 4B 
 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits 
Day 
(Window) 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
45 
(±3) 
84 
(±5) 
126 
(±7) 
168 
(±14) 
206 a 
(±10) 
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) 
 
X 
X b 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Safety ECG c 
X 
X 
X 
 
 
X 
 
 
 
 
X 
 
 
 
 
X 
Holter Monitor ECG d 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
X 
 
X 
X e 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Lipids, coagulation, complement 
activation f 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (HBV, HCV, 
HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virology screening (SARS-CoV-2) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum/urine pregnancy test, FSH g 
X 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
Drug/alcohol screen h 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dosing of study drug 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reactogenicity/injection site 
inspection i 
 
 
X  
X  
X 
 
 
 
 
 
 
 
 
 
 
 
PK sample collection j 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite 
identification and CD388 DAR 
distribution k 
 
 
X 
X 
 
 
 
 
X 
 
X 
 
X 
X 
 
 
Samples for CD388 glycoforms l 
 
 
predose 
X 
 
X 
 
 
X 
X 
X 
X 
 
X 
 
 


Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 18 of 85 
 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits 
Day 
(Window) 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
45 
(±3) 
84 
(±5) 
126 
(±7) 
168 
(±14) 
206 a 
(±10) 
Pharmacogenomics blood sample m 
 
 
predose 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exploratory biomarker samples 
 
 
predose 
 
X e 
 
 
 
 
 
 
 
 
 
 
 
Anti-drug antibodies 
 
 
predose 
 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
Nasopharyngeal swab/nasal wash 
collection n 
 
 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Assess and record AEs o 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/
procedures review p 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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; OV = outpatient visit; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe 
acute respiratory syndrome coronavirus 2. 
Schedule of Events: Single Dose, Cohort 4B 
a. For subjects who discontinue study early, the Day 206 procedures should be performed. 
b. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated.  
c. 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 and semi-recumbent when ECG is being conducted. 
d. Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG tracings, including all 12-leads 
and of 10 seconds duration, will be extracted in triplicate for 5-minute observation period starting from 1 hour before dosing, then at 72, 76, 80, 84, 96, 102, 
106, 110, 118, and 120 hours after administration of study drug, and stored in a digital format. The Holter monitor will be removed on Day 6. The Holter 
monitor may be removed once on Day 5 for up to 15 minutes for shower/bathing, at least 1 hour away from the next ECG timepoint. 
e. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
f. 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). 
g. A sensitive serum pregnancy test (β‑human chorionic gonadotropin) is required at screening and OV4 for females of childbearing potential. 
FSH (if applicable to confirm postmenopausal status) is only required once. Urine pregnancy test may be performed at all other time points. 
h. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see Appendix 2). 
i. 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), with any abnormal findings reported as AEs. Reactions will be rated according to the scale provided in 
Table 7. 


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Schedule of Events: Single Dose, Cohort 4B (continued) 
j. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 12 and 24 hours (±30 minute window); 48 hours (±1 hour window); 
72, 84, 96, 108, 120 hours (each ±2 hour window); and Days 7, 9, 11, 14, 21, 30 (each ±2 hour window). Postdose samples collected at outpatient CRU visits 
at Days 45, 84, 126, 168, and 206 have the same windows (i.e., in ±days) as the visits. 
k. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) will be collected on Day 1 at 2 hours postdose, on Day 2 at 24 hours 
postdose, on Day 30, Day 84, and on Day 126. Urine samples for metabolite identification will be collected from 0–48 hours, from 48–96 hours, and from 
96–144 hours postdose, and over a 24 hour period on Days 10, 14, and 21, and over a 24-hour period that starts on Day 29 and ends prior to CRU check-out 
on Day 30. 
l. Serum samples for CD388 glycoforms will be collected predose on Day 1 and once in the morning on Days 2, 7, 14, 21, and 30, and at the Day 45 and 
Day 126 visits. 
m. 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. 
n. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. Nasal wash collection will occur on Day 7. 
o. 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 205 days after the dose of study drug (Day 206 ±10 days) (this final AE assessment will be conducted via a follow-up phone call to the 
subject). 
p. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit.  
 


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1.2. 
Study Schema 
 
 


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2. 
TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS .............................................................................................3 
1.1. 
Schedule of Events .....................................................................................................12 
1.1.1. 
First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B ...........................................12 
1.1.2. 
Second Single Dose, Cohorts 2A, 2B, 3A, and 3B .....................................................15 
1.1.3. 
Single Dose, Cohort 4B ..............................................................................................17 
1.2. 
Study Schema .............................................................................................................20 
2. 
TABLE OF CONTENTS ...........................................................................................21 
2.1. 
LIST OF TABLES ......................................................................................................25 
3. 
LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF 
TERMS .......................................................................................................................26 
4. 
BACKGROUND AND RATIONALE .......................................................................28 
4.1. 
Background .................................................................................................................28 
4.1.1. 
Influenza – Prevention and Treatment ........................................................................28 
4.1.2. 
CD388 – A Long-Acting Antiviral Fc-Conjugate ......................................................29 
4.1.2.1. 
CD388 Nonclinical Studies ........................................................................................29 
4.2. 
Summary of Benefits and Risks .................................................................................30 
4.3. 
Justification of Dose ...................................................................................................30 
4.4. 
Population to be Studied .............................................................................................31 
4.5. 
Rationale for Trial Endpoints .....................................................................................31 
4.6. 
Statement of Compliance ............................................................................................32 
5. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................33 
6. 
STUDY DESIGN .......................................................................................................35 
6.1. 
Description of the Study .............................................................................................35 
6.2. 
Criteria for Evaluation ................................................................................................37 
6.2.1. 
Safety and Tolerability of Study Drug ........................................................................37 
6.2.2. 
Pharmacokinetics/Anti-drug Antibodies ....................................................................38 
6.2.3. 
Pharmacogenomics .....................................................................................................38 
6.2.4. 
Exploratory Biomarkers ..............................................................................................38 
6.3. 
Number of Subjects ....................................................................................................39 
6.4. 
Measures Taken to Minimize Bias .............................................................................39 
6.5. 
Expected Duration of Subject Participation ...............................................................39 


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6.6. 
Method of Treatment Assignment and Blinding ........................................................39 
6.7. 
Data Review Committee .............................................................................................40 
7. 
SELECTION, DISCONTINUATION, AND WITHDRAWAL OF 
SUBJECTS .................................................................................................................41 
7.1. 
Subject Inclusion Criteria ...........................................................................................41 
7.2. 
Subject Exclusion Criteria ..........................................................................................42 
7.3. 
Requalification for Entry ............................................................................................43 
7.4. 
Subject Withdrawal Criteria .......................................................................................44 
7.4.1. 
Subject Stopping Rules ...............................................................................................44 
7.4.2. 
Withdrawal from Study Protocol ................................................................................44 
7.5. 
Replacement of Subjects .............................................................................................44 
7.6. 
Temporary Study Halt for Safety Review ..................................................................45 
7.7. 
Study Termination by Sponsor and Termination Criteria ..........................................45 
8. 
STUDY DRUG ...........................................................................................................46 
8.1. 
CD388 Injection ..........................................................................................................46 
8.1.1. 
Directions for Use .......................................................................................................46 
8.1.2. 
Drug Storage ...............................................................................................................46 
8.1.3. 
Dose Adjustment ........................................................................................................46 
8.2. 
Placebo Injection ........................................................................................................46 
8.3. 
Compliance .................................................................................................................46 
8.4. 
Breaking the Blind ......................................................................................................46 
8.5. 
Previous and Concomitant Medications and Substances ............................................47 
8.6. 
Accountability Procedures ..........................................................................................47 
8.7. 
Study Drug Handling and Disposal ............................................................................47 
9. 
STUDY PROCEDURES ............................................................................................48 
9.1. 
Medical History ..........................................................................................................48 
9.2. 
Physical Examinations ................................................................................................48 
9.3. 
Vital Signs ..................................................................................................................48 
9.4. 
Electrocardiograms .....................................................................................................48 
9.5. 
Laboratory Evaluations ...............................................................................................49 
9.6. 
Randomization ............................................................................................................50 
9.7. 
Pharmacokinetics, Metabolite Identification, Pharmacogenomics, 
Exploratory Biomarkers, and Anti-drug Antibodies ..................................................50 


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9.8. 
Reactogenicity/Injection Site Inspection ....................................................................51 
9.9. 
Nasopharyngeal Swab and Nasal Wash Collections ..................................................51 
9.10. 
Adverse Events ...........................................................................................................51 
9.11. 
Prior and Concomitant Medications and Concomitant Procedures ............................52 
10. 
ASSESSMENT OF EFFICACY ................................................................................53 
11. 
ASSESSMENT OF SAFETY .....................................................................................54 
11.1. 
Safety Parameters .......................................................................................................54 
11.2. 
Adverse Events ...........................................................................................................54 
11.3. 
Adverse Event Reporting ............................................................................................55 
11.3.1. 
Notification of Serious Adverse Events .....................................................................55 
11.3.2. 
Notification of Emerging Safety Issues ......................................................................56 
11.4. 
Definitions ..................................................................................................................56 
11.4.1. 
Adverse Event .............................................................................................................56 
11.4.2. 
Suspected Adverse Reaction .......................................................................................56 
11.4.3. 
Life-Threatening AE or Life-Threatening Suspected Adverse Reaction ...................57 
11.4.4. 
Serious Adverse Event or Serious Suspected Adverse Reaction ................................57 
11.4.5. 
Unexpected AE or Unexpected Suspected Adverse Reaction ....................................57 
11.4.6. 
Adverse Events of Special Interest .............................................................................58 
11.4.7. 
Emerging Safety Issue ................................................................................................58 
11.4.8. 
Urgent Safety Measure ...............................................................................................58 
11.5. 
Adverse Event Classification ......................................................................................58 
11.5.1. 
Relationship to Study Drug ........................................................................................58 
11.5.2. 
Severity .......................................................................................................................59 
11.5.3. 
Serious Adverse Event ................................................................................................59 
11.6. 
Adverse Event Follow Up ..........................................................................................59 
11.7. 
Adverse Event Management .......................................................................................59 
11.8. 
Risks for Women of Childbearing Potential or During Pregnancy ............................60 
12. 
STATISTICAL METHODS .......................................................................................61 
12.1. 
Analysis Populations ..................................................................................................61 
12.2. 
Analysis of Study Population and Subject Characteristics .........................................61 
12.3. 
Safety Analyses ..........................................................................................................61 
12.4. 
Pharmacokinetic Analyses ..........................................................................................62 


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12.5. 
Analyses of Metabolite Identification, Pharmacogenomics, Exploratory 
Biomarkers, and Anti-Drug Antibodies ......................................................................62 
12.6. 
Interim Analysis ..........................................................................................................63 
12.7. 
Determination of Study Sample Size ..........................................................................63 
12.8. 
Handling of Dropouts and Missing, Unused, and Spurious Data ...............................63 
12.9. 
Subject Disposition .....................................................................................................63 
12.10. 
Deviation Reporting ....................................................................................................63 
13. 
INVESTIGATOR REQUIREMENTS .......................................................................64 
13.1. 
Protocol Adherence ....................................................................................................64 
13.2. 
Electronic Case Report Forms ....................................................................................64 
13.3. 
Source Document Maintenance ..................................................................................64 
13.4. 
Study Monitoring Requirements .................................................................................64 
13.5. 
Study Completion .......................................................................................................64 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................66 
15. 
PROTECTION OF HUMAN SUBJECTS .................................................................67 
15.1. 
Informed Consent .......................................................................................................67 
15.2. 
IRB/IEC Approval ......................................................................................................67 
16. 
DATA HANDLING AND RECORD KEEPING ......................................................68 
16.1. 
Direct Access to Source Data/Documentation ...........................................................68 
16.2. 
Study Drug Accountability .........................................................................................68 
16.3. 
Retention of Records ..................................................................................................68 
16.4. 
Long-term Retention of Samples for Additional Future Research .............................69 
17. 
FINANCING AND INSURANCE .............................................................................70 
18. 
PUBLICATION POLICY ..........................................................................................71 
19. 
REFERENCES ...........................................................................................................72 
20. 
APPENDICES ............................................................................................................73 
APPENDIX 1. ACCEPTABLE METHODS OF CONTRACEPTION......................................74 
APPENDIX 2. ECG AND VITAL SIGN ABNORMALITIES .................................................75 
APPENDIX 3. DIAGNOSTIC CRITERIA AND MANAGEMENT FOR 
ANAPHYLAXIS ........................................................................................................76 
APPENDIX 4. RASH MANAGEMENT....................................................................................78 
APPENDIX 5. VISIT SCHEDULE FOR RASH MANAGEMENT FOR ADULT 
SUBJECTS .................................................................................................................83 


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APPENDIX 6. INVESTIGATOR SIGNATURE .......................................................................85 
 
 
2.1. 
LIST OF TABLES 
Table 1: 
Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B ..........12 
Table 2: 
Schedule of Events: Second Single Dose, Cohorts 2A, 2B, 3A, and 3B ....................15 
Table 3: 
Schedule of Events: Single Dose, Cohort 4B .............................................................17 
Table 4: 
Dose Levels and Safety Margins (Animal-to-Human Dose Ratios) for the 
Proposed CD388 First-in-Human 50 mg Dose ...........................................................31 
Table 5: 
Study Design ...............................................................................................................36 
Table 6: 
Clinical Laboratory Tests ...........................................................................................49 
Table 7: 
Injection Site Evaluation .............................................................................................51 
Table 8: 
Guidelines for Assessing Relationship of Event to Study Drug .................................58 
Table 9: 
Guidelines for Severity Assessments ..........................................................................59 
 
 


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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–t 
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 
CK 
creatine kinase 
CL/F 
apparent clearance  
Cmax 
maximum plasma (or nasopharyngeal) concentration 
COVID-19 
coronavirus disease 2019 
CrCL 
creatinine clearance 
CRU 
clinical research unit 
DAR 
drug-antibody ratio 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunoassay 
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 


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Abbreviation 
Definition 
IEC 
Independent Ethics Committee 
IgG1 
immunoglobulin G1 
IM 
intramuscular 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
NA 
neuraminidase 
NAI 
neuraminidase inhibitor 
NCA 
non-compartmental analysis 
NOAEL 
no-observed-adverse-effect level 
NP 
nasopharyngeal 
OTC 
over-the-counter 
OV 
outpatient visit 
PCR 
polymerase chain reaction 
PI 
Principal Investigator 
PK 
pharmacokinetic(s) 
PT 
Preferred Term 
SAE 
serious adverse event 
SAER 
Serious Adverse Event Report 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SQ 
subcutaneous 
t½ 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
TM 
targeting molecule 
Tmax 
time to maximum plasma (or nasopharyngeal) concentration 
ULN 
upper limit of normal 
US 
United States 
VZ/F 
apparent volume of distribution 
 


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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: 
• 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). 
• 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. 
• 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-γ 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. 
In vitro stability of the TM compound alone was quantitatively tested at 37℃ in phosphate-
buffered saline, plasma, and liver microsomes. Stability of the intact Fc-conjugated molecule, 
CD388, was qualitatively observed in liver microsomes at 37℃. In vivo, the 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 immunoassay (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. 
4.2. 
Summary of Benefits and Risks 
This is a FIH study of CD388 Injection. More detailed information about the known 
and expected benefits and risks and reasonably expected adverse events (AEs) may be found in 
the Investigator’s Brochure. 
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 
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 30 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 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 FIH proposed dose are 
presented in Table 4. At the proposed 50 mg human dose administered as a bolus IM or 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. 


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Table 4: 
Dose Levels and Safety Margins (Animal-to-Human Dose Ratios) for the 
Proposed CD388 First-in-Human 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-∞ = 3855 µg×h/mL. 
Cmax = 14.4 µg/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 from this trial have indicated no significant safety findings following single IM 
or SQ administration of 50, 150 mg, and 450 mg CD388. Regular assessment of blinded 
safety/tolerability data from 66 healthy subjects who received a dose of 50 mg, 150 mg, or 
450 mg of IM or SQ CD388 or placebo has not identified any concerning safety observations to 
date. 
In summary, excellent safety margins were achieved with CD388 in 3-month toxicity studies 
relative to the proposed FIH human dose conservatively scaled to BSA and to the predicted FIH 
plasma exposure. Although no adverse findings were identified, 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. Results from this FIH study to date have shown no concerning safety 
findings after 50 mg, 150 mg, and 450 mg single-dose CD388 administrations. 
4.4. 
Population to be Studied 
Healthy 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 


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for determining the plasma and urine 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 on 
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 
(ICH) E6 Good Clinical Practice (GCP), and applicable regulatory and Institutional Review 
Board (IRB) requirements. 


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5. 
STUDY OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
 
• To determine the safety and tolerability profile 
of CD388 Injection when dosed either by 
intramuscular (IM) or subcutaneous (SQ) 
administration as a single dose to healthy adult 
subjects. 
• 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 
 
• To determine the plasma pharmacokinetic (PK) 
profile of CD388 Injection when dosed either 
by IM or SQ administration following a single 
dose and a repeated single dose to healthy adult 
subjects. 
• 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-t), area under the plasma 
concentration-time curve from time 0 extrapolated to 
infinity (AUC0-∞). 
• To determine the safety and tolerability profile 
of CD388 Injection when dosed either by IM 
or SQ administration as a repeated single dose 
(after washout of 3 months or 5 effective 
half -lives from the first dose; whichever is 
longer) to healthy adult subjects. 
• Incidence and severity of TEAEs, including but not 
limited to AEs and SAEs (including systemic 
reactogenicity/injection site reactions and 
hypersensitivity reactions), AEs leading to study drug 
discontinuation and/or study withdrawal, vital signs, 
ECGs, and clinical laboratory tests (including 
hematology, coagulation, serum chemistry, 
and urinalysis) after a repeated single dose of CD388. 
Exploratory 
• To determine the PK profile of CD388 Injection 
in upper respiratory tract after IM or SQ 
administration as a single dose to healthy adult 
subjects. 
• 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-t). 
• To identify CD388 metabolites in plasma, 
CD388 and its metabolites in urine, and CD388 
drug-antibody ratio (DAR) distribution in 
plasma, and CD388 glycoforms in serum after 
IM or SQ administration to healthy adult 
subjects. 
• CD388 metabolites (e.g., free zanamivir, zanamivir 
dimers) in plasma and urine, CD388 in urine 
and nasal wash, CD388 DAR distribution in plasma, 
and CD388 glycoforms in serum, to be reported 
separately. 
• To evaluate biomarkers that may be associated 
with AEs after CD388 Injection. 
• Results of the analyses of exploratory biomarkers 
(including but not limited to cytokines, chemokines, 
acute phase reactants, etc.). 
• To evaluate CD388 immunogenicity. 
• Anti-drug antibody titers in blood (plasma or serum). 


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Objectives 
Endpoints 
• To explore pharmacogenomics related to 
CD388. 
• Results of the analyses of pharmacogenomic samples, 
to be reported separately. 
• To explore the effects on cardiac safety in 
subjects administered CD388 Injection. 
• 12-lead ECG and Holter monitoring parameters. 
• To explore the effect of CD388 Injection on the 
occurrence of influenza-like illness (during flu 
season). 
• 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 FIH, Phase 1, single-center, prospective, randomized, double-blind study of ascending 
single doses of CD388 Injection administered IM or SQ to healthy adult subjects followed by 
another single dose of CD388 Injection administered by the same route 3 months or 5 effective 
half-lives, whichever is longer, after the first dose in the middle and high dose groups (dosing 
may be adjusted for tolerability). The goals are to assess safety, tolerability, immunogenicity 
(anti-drug antibodies [ADA]), and PK of CD388. 
Dose levels of CD388 to be assessed will follow an ascending single dose design with the 
starting dose based on findings from 3-month rat and monkey toxicology studies. Within each 
route (IM and SQ dose, route assignment is unblinded), subjects will be randomized to receive 
a single dose of CD388 Injection or saline placebo (treatment assignment is blinded) according 
to the design in Table 5. It should be noted that each cohort will be divided into 2 groups 
identified as “sentinel” groups (randomized 1:1) and “main” groups (randomized 7:2): 
• 
Low dose (50 mg) level: Cohort 1A (IM) and Cohort 1B (SQ) – each route n = 2 sentinel and n = 9 main 
• 
Mid dose (150 mg) level: Cohort 2A (IM) and Cohort 2B (SQ) – each route n = 2 sentinel and n = 9 main 
• 
High dose (450 mg) level: Cohort 3A (IM) and Cohort 3B (SQ) – each route n = 2 sentinel and n = 9 main 
• 
Highest dose (900 mg) level: Cohort 4B (SQ) – n = 2 sentinel and n = 9 main 
For each route, the sentinel or first group of 2 subjects (1 CD388: 1 placebo) at a dose level 
will be administered blinded study drug and closely monitored for safety for at least 1 week. 
The Principal Investigator (PI) and Sponsor will review blinded safety data after the initial 
sentinel group subjects at a dose level have completed dosing and followed for a minimum of 
1 week. If no drug-related SAEs or drug-related Grade ≥3 AEs have occurred, the subjects in 
the corresponding main group may be dosed within 24 hours. The observation duration may be 
adjusted for the sentinel groups in Cohorts 2A, 2B, 3A, 3B, and 4B based on data from previous 
cohorts. 
After all subjects at a dose level (for the IM cohorts and SQ cohorts separately) have completed 
study drug administration and have undergone protocol-specified procedures and assessments 
for ≥14 days, the PI and Sponsor will review blinded safety data, including AEs (including 
reactogenicity/injection site reactions and hypersensitivity reactions), vital signs, 12-lead ECGs, 
and clinical laboratory results (including hematology, coagulation, serum chemistry, 
and urinalysis) to determine the safety and tolerability of the study drug. The incidence and 
severity of AEs, and adverse changes in vital signs, clinical laboratory findings, and ECGs will 
be taken into consideration when determining safety and tolerability of study drug. Escalation 
between dose levels will be based on review of at least 14-day post-dose safety data. If the 
dose/route of administration is determined to be safe and well tolerated ≥14 days after dosing, 
the next cohort of subjects will be enrolled and randomized to receive the next higher dose level 
of CD388 Injection or placebo. The data cut-off time point for data review and dose escalation 
decision has been adjusted for Cohorts 2A, 2B, 3A, and 3B based on data from Cohorts 1A and 
1B. 


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Table 5: 
Study Design 
Dose (mg) a 
Number of Subjects (N = 77) 
Intramuscular (IM) 
Subcutaneous (SQ) 
Cohort 
CD388 
(n = 24) 
Placebo 
(n = 9) 
Cohort 
CD388 
(n = 32) 
Placebo 
(n = 12) 
50 
Cohort 1A (sentinel) 
1 
1 
Cohort 1B (sentinel) 
1 
1 
50 
Cohort 1A (main) 
7 
2 
Cohort 1B (main) 
7 
2 
150 
Cohort 2A (sentinel) 
1 
1 
Cohort 2B (sentinel) 
1 
1 
150 
Cohort 2A (main) 
7 
2 
Cohort 2B (main) 
7 
2 
450 
Cohort 3A (sentinel) 
1 
1 
Cohort 3B (sentinel) 
1 
1 
450 
Cohort 3A (main) 
7 
2 
Cohort 3B (main) 
7 
2 
900 
NA 
NA 
NA 
Cohort 4B (sentinel) 
1 
1 
900 
NA 
NA 
NA 
Cohort 4B (main) 
7 
2 
Abbreviation: NA = not applicable. 
Note: Immediately prior to the second single dose, within each dose and route, any dropouts  in the sentinel groups will be 
randomly replaced with subjects from the main groups, retaining their original treatment assignment (i.e., subjects assigned to 
placebo will remain placebo, and subjects assigned to CD388 will remain CD388). 
 
Subjects in Cohort 4B will receive a single dose of CD388 Injection or placebo (SQ). 
Subjects in Cohorts 2A and 2B and Cohorts 3A and 3B will receive a second single dose of 
CD388 Injection or placebo after washout of 5 effective half-lives after the first dose if it is 
determined that the safety and tolerability of the first dose is acceptable upon review of the 
cumulative safety data. Immediately prior to the second single dose, within each dose and route, 
any dropouts in the sentinel groups will be randomly replaced with subjects from the main 
groups, retaining their original treatment assignment (i.e., subjects assigned to placebo will 
remain placebo, and subjects assigned to CD388 will remain CD388; this may require unblinded 
personnel to oversee).  
The PI and Sponsor will review blinded safety data after the initial sentinel group subjects at 
a dose level have completed dosing and followed for the minimum observation period as 
determined during the first single dose. If no drug-related SAEs or drug-related Grade ≥3 AEs 
have occurred, the subjects in the corresponding main group may be dosed within 24 hours. 
The dose escalation scheme is presented in Section 1.2. 
The Schedule of Events is presented in Table 1 (first single dose, Cohorts 1A, 1B, 2A, 2B, 3A, 
3B), Table 2 (second single dose, Cohorts 2A, 2B, 3A, and 3B), and Table 3 (single dose, Cohort 
4B). All subjects will be admitted to the clinical research unit (CRU) for observation and safety 
assessments from Day -1 (check-in) to Day 30. Subjects will be monitored for AEs (including 
reactogenicity/injection site reactions and hypersensitivity reactions) and SAEs as indicated 
below: 


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Cohort 
AE/SAE monitoring period from signing of ICF: 
1A, 1B 
Through 4 months after the dose of study drug  
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
Abbreviation: ICF = informed consent form. 
Safety will also be assessed by physical examinations, ECGs, vital signs measurements, 
and laboratory evaluations (hematology, coagulation, serum chemistry, and urinalysis) at various 
time points during and after the CRU stay. Concomitant medication use will be recorded 
throughout the study.  
Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG 
monitor as indicated below: 
Cohort 
Holter Monitoring Period 
1A, 1B 
1 hour before administration of study drug until 48 hours after dosing 
2A, 2B, 3B 
1 hour before first administration of study drug until 48 hours after dosing a 
3A 
Predose from 1 hour before administration of first single dose until administration is 
complete, and from 72 to 120 hours after dosing a 
4B 
Predose from 1 hour before administration of single dose until administration is 
complete, and from 72 to 120 hours after dosing 
Note: Timing of ECG monitoring has been adjusted for Cohort 3A and 4B based on PK and ECG data. 
a. Performed at the second administration period only if required to further evaluate observations from prior 
peri-dosing period (at the discretion of the Investigator). 
Blood PK samples, and blood samples to assess ADA will be collected from all subjects for 
the purpose of maintaining the blind, but only samples from the CD388 Injection group will be 
analyzed (using validated assays) by an unblinded central bioanalytical laboratory. After 
discharge from the CRU, additional sample collection for PK and ADA will be performed at 
specified time points after dosing. The timing of PK sampling has been adjusted for Cohorts 2A, 
2B, 3A, and 3B based on data from previous cohorts. 
Additional blood samples will be collected for pharmacogenomics and exploratory biomarker 
evaluation, and additional blood and urine samples will be collected for exploratory metabolite 
identification, to be reported separately. Plasma samples collected for PK analysis may also be 
used for CD388 drug-antibody ratio (DAR) distribution and metabolite identification after 
completion of PK analysis. Nasopharyngeal swabs will also be collected for CD388 exploratory 
assays. Nasal wash collection will occur during the second single dose at the time of Cmax as 
determined from the first single dose. Nasal wash collection for Cohort 4B will occur during 
dosing on Day 7. 
6.2. 
Criteria for Evaluation 
6.2.1. 
Safety and Tolerability of Study Drug 
Safety and tolerability will be assessed by monitoring AEs (including reactogenicity/injection 
site reactions, hypersensitivity reactions, and adverse events of special interest [AESIs]), vital 
signs, 12-lead ECGs, Holter monitoring, clinical laboratory results (including hematology, 


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coagulation, serum chemistry, and urinalysis), and concomitant medication usage throughout the 
study. 
See Section 6.1 for details regarding dose level/cohort 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. 
If any subject develops a Grade ≥2 AE 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 and route 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 the first and second single doses of the study drug. Blood samples collected for 
PK analysis may also be used for metabolite identification after completion of PK analysis, along 
with urine samples. Plasma samples, nasopharyngeal swabs, and nasal washes will be analyzed 
for the concentration of CD388. Anti-drug antibodies (ADA) 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 allowed 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. They may also be used to develop 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 (such as but not 
limited to RNA or proteins) on the assumption that these markers may 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. They may also be used to develop tests/assays related to CD388 
and influenza. 


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Analyses of biomarkers may be conducted at the Sponsor’s discretion and reported separately 
from the study report. 
6.3. 
Number of Subjects 
Up to 77 subjects will be enrolled in this study, with approximately 56 of these subjects expected 
to receive CD388 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 the final study database is locked. 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. 
Administration route assignment (IM or SQ) is not blinded. 
6.5. 
Expected Duration of Subject Participation 
A single dose of study drug will be administered IM or SQ on Day 1. Study participation 
will require up to 28 days for screening procedures, and ~120 days for the first single dose 
(check-in to the CRU on Day -1; CRU inpatient stay for study drug administration, observation, 
and assessments and procedures for 31 days [Days -1 to Day 30]; and 4 CRU outpatient visits 
for additional assessments and procedures). 
Subjects in Cohorts 2A, 2B, 3A, and 3B who receive a second single dose will have an additional 
168 days of participation, with similar study visits to that of the first administration. 
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 route (IM and SQ dose, route assignment is unblinded), 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 the study drug 
assignment via an Interactive Response Technology (IRT) or by a manual paper transaction. 
A subject is considered randomized when a randomization transaction is recorded in the IRT 
or the subject’s source documents if performed manually. 
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 


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performed by an unblinded site pharmacist (or qualified unblinded personnel at the study site not 
involved with study procedures or evaluations). 
Instructions for study drug preparation and dosing are outlined in the Pharmacy Manual provided 
separately to the site. In the case 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 
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 the following inclusion criteria: 
1. Willing and able to provide written informed consent. 
2. Males and females 18 to 65 years of age, inclusive. 
3. 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 205 days 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) or in a menopausal state (at least 1 year without menses), 
as confirmed by follicle-stimulating hormone (FSH) levels (≥40 mIU/mL). 
4. A woman of childbearing potential must have a negative highly sensitive serum 
pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine 
pregnancy test on Day -1 before the first dose of study drug. 
5. 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 to not donate sperm 
during the study and until at least 205 days after the last dose of the study medication. 
6. Good health and without signs or symptoms of current illness. 
7. 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) ≥80 mL/min as calculated using the Cockcroft-Gault 
equation: 
𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶= 
(140 −𝑎𝑎𝑎𝑎𝑎𝑎) × (𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 𝑖𝑖𝑖𝑖 𝑘𝑘𝑘𝑘)
72 × (𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 𝑖𝑖𝑖𝑖 𝑚𝑚𝑚𝑚/𝑑𝑑𝑑𝑑) × (0.85 𝑖𝑖𝑖𝑖 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓) 
d. Negative urine screen for drugs of abuse and alcohol at screening and Day -1. 
8. Body mass index (BMI; weight in kg divided by height in m squared) between 18.0 
and 32.0 kg/m2, inclusive. 
9. 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. 


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10. 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. 
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. Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN]) 
b. Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN) 
c. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 
(≥1.25 × ULN) 
d. Total bilirubin, Grade ≥1 (≥1.1 × ULN) 
e. Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, 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. 


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4. Alcohol or drug addiction in the past 2 years. 
5. Experiencing symptoms of acute illness or chronic disease within 14 days prior to 
check-in to the CRU. 
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 screening or CRU check-in for severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Beginning with 
Protocol Amendment 2, antigen testing may be used if PCR is not available. 
8. Unwilling to comply with local health policy effective at the time regarding coronavirus 
disease 2019 (COVID-19).* 
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. 
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 when participating in 
non-interventional clinical trials within 60 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. Previous participation in 
another study within 30 days 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. The PI considers that the volunteer should not participate in the study. 
* Full COVID-19 vaccination prior to participation is strongly recommended. 
** In the event a subject chooses to receive one of the two 2-dose approved or emergency-use-
authorized COVID-19 vaccines (Comirnaty® [Pfizer], Spikevax™ [Moderna]) in the interval 
between two CRU stays (Cohort 2A/2B or Cohort 3A/3B), flexibility in timing of the second 
CRU stay should be applied, to allow appropriate receipt of the second vaccine dosage or 
booster (based on the respective vaccine label) + 14 days, to minimize risk of confounding 
findings/observations. 
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. 


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7.4. 
Subject Withdrawal Criteria 
7.4.1. 
Subject Stopping Rules 
Subjects in Cohorts 2A, 2B, 3A, and 3B will be followed through Outpatient Visit 4 (OV4) of 
the first dosing period, and will not receive the second single dose: 
• If the subject develops anaphylaxis or a related Grade 3 or Grade 4 AE 
• If the subject has a persistent (i.e., >5 days with no response to treatment) Grade ≥2 rash 
considered related to the investigational drug by the Principal Investigator (Appendix 4) 
• If the Investigator believes that it is in the best interest of the subject to not receive 
a second dose 
• If the subject no longer meets all eligibility criteria prior to the second single dose 
• If the subject becomes pregnant prior to the second single dose 
If a subject is removed from the study for any reason, the subject will be followed for resolution 
of any ongoing AE(s). 
7.4.2. 
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 OV4 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: 
• Subject is unable or unwilling to continue 
• Subject elects to withdraw informed consent 
• 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 
• Protocol non-compliance 
• Subject lost to follow-up, or follow-up is not possible 
• The Investigator considers that it is in the subject’s best interest not to continue 
participation in the study 
7.5. 
Replacement of Subjects 
Subjects who are withdrawn for reasons other than AEs may be replaced at the discretion of the 
Sponsor. 


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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:  
• If ≥2 subjects experience the same Grade 3 AE event or laboratory abnormality within 
28 days after study drug administration, considered attributable to CD388 or cannot be 
attributed to another cause 
(Investigator to consider the potential of IM injections to cause significant transient 
increases of creatine kinase [CK], when evaluating the potential relatedness of this 
laboratory abnormality to the investigational drug. A transient CK increase after IM 
injection is to be considered “not related” to the study drug.) 
• If ≥1 subject experiences a Grade 4 AE or laboratory abnormality 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, 
a substantial amendment 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. 
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: 
• The incidence or severity of AEs indicate a potential health hazard to subjects. 
• Serious or persistent noncompliance by the Investigator with the protocol, clinical 
research agreement, or applicable regulatory guidelines in conducting the study. 
• Institutional Review Board (IRB)/Independent Ethics Committee (IEC) decision to 
terminate or suspend approval for the investigation or the Investigator. 
• Investigator request to withdraw from participation. 
• 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 either IM or SQ injection at the dose described in Table 5, 
depending upon the subject’s randomization assignment. 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 should be 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 IM or 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 


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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. 
The Sponsor may conduct an interim analysis of selected safety and efficacy study data. Study 
team members involved in day-to-day trial related activities will not have access to interim 
analysis data which might unblind them at the subject level. Unblinding at treatment/group level 
is permitted as needed to enable the analysis. After the database is locked and the Statistical 
Analysis Plan (SAP) is final, the study blind codes will be broken.  
8.5. 
Previous and Concomitant Medications and Substances 
All medications administered within 30 days prior to study drug administration and throughout 
the study will be documented and recorded in the eCRF. 
Subjects must refrain from over-the-counter (OTC) 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, Table 2, Table 3) 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 and semi-recumbent for safety 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. 
Continuous digital ECG recording will be performed using a 12-lead Holter ECG monitor.  
• For Cohorts 1A, 1B, 2A, 2B, and 3B:  
Pharmacodynamic ECG tracings, including all 12-leads and of 10 seconds duration, will 
be extracted in triplicate at prespecified time points for a 5-minute observation period 
starting from 1 hour before dosing until 48 hours after administration of study drug 
(expected time to maximum concentration is 1 to 2 days after administration), and stored 
in a digital format. Holter monitoring may be longer or shorter depending on available 
PK data. Subjects should be resting and semi-recumbent for 15 minutes prior to the first 
predose Holter ECG monitor data extraction time point until the 2-hour PK sample 
collection and Holter ECG monitoring data extraction. Subjects may use the restroom 
during this period, except for the 15-minute window prior to ECG data extraction and for 


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the duration of the observation period. For later time points, subjects will be similarly 
positioned, at rest, and without any other procedures (except those required by the 
protocol), food, or undue stimulation for the 15 minutes prior to and for the duration of 
the observation period. 
The Holter monitor may be removed once on Day 2 for up to 15 minutes for 
shower/bathing, at least 2 hours away from the next ECG timepoint (i.e., 30, 36, or 
48 hours postdose).  
• For Cohorts 3A and 4B ONLY:  
Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG 
monitor. Pharmacodynamic ECG tracings, including all 12 leads and of 10 seconds 
duration, will be extracted in triplicate at prespecified time points for a 5-minute 
observation period starting from 1 hour before dosing, then at 72, 76, 80, 84, 96, 102, 
106, 110, 118, and 120 hours after administration of study drug, and stored in a digital 
format. 
The Holter monitor may be removed once on Day 5 for up to 15 minutes for shower/
bathing, at least 1 hour away from the next ECG timepoint. The Holter monitor will be 
removed on Day 6. 
9.5. 
Laboratory Evaluations 
Blood and urine for laboratory evaluations will be collected and analyzed at a local/site 
laboratory in accordance with quality laboratory standards. Hematology, serum chemistry, 
coagulation, urinalysis, and other parameters to be tested are listed in Table 6. 
Table 6: 
Clinical Laboratory Tests 
Laboratory 
Test Category 
Specific Laboratory Tests 
Hematology: a 
Hemoglobin 
Neutrophils (absolute) 
Hematocrit 
Monocytes 
Erythrocyte (red blood count [RBC]) count 
Eosinophils 
Quantitative platelet count 
Lymphocytes 
Total leukocyte (white blood cell [WBC]) 
count 
Basophils 
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 
Total bilirubin (if total bilirubin is 
≥2 × 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) 


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Laboratory 
Test Category 
Specific Laboratory Tests 
Phosphorus 
Amylase 
Creatinine Clearance (Cockcroft-Gault) b 
 
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 
Pregnancy: e 
Serum beta human chorionic gonadotropin 
(β-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 
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 (Tables 1, 2, and 3).  
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, Metabolite Identification, Pharmacogenomics, 
Exploratory Biomarkers, and Anti-drug Antibodies 
Blood and urine samples for pharmacokinetic analysis, metabolite identification, CD388 DAR 
distribution, CD388 glycoforms, pharmacogenomics, exploratory biomarkers, and anti-drug 


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antibodies will be collected as indicated in the Schedule of Events (Table 1, Table 2, Table 3). 
Refer to the laboratory manual for instructions on collection of these samples for analysis. 
9.8. 
Reactogenicity/Injection Site Inspection 
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), with any abnormal findings reported as AEs. Reactions will be rated 
according to Table 7. 
Table 7: 
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. 
Nasopharyngeal Swab and Nasal Wash Collections 
Refer to the laboratory manual for instructions on collection of samples from nasopharyngeal 
swab and nasal wash for exploratory CD388 assays.  
9.10. 
Adverse Events  
Information on AEs (event term, start and stop dates, severity, relationship to blinded study drug) 
will be collected as indicated below: 
Cohort 
AE monitoring period from signing of Informed Consent Form: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
See Section 11 for additional information. 


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9.11. 
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 reactogenicity/injection 
site reactions and hypersensitivity reactions), vital signs, 12-lead ECGs, clinical laboratory 
results (including hematology, coagulation, serum chemistry, and urinalysis), and concomitant 
medication usage throughout the study. 
11.2. 
Adverse Events 
Adverse events will be collected as indicated below:  
Cohort 
AE monitoring period from signing of Informed Consent Form: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
The Investigator will assess all AEs and SAEs and will record the following information 
on the appropriate eCRF page: 
• Date of onset 
• Resolution status, and date of resolution or stabilization if achieved 
• Seriousness 
• Severity 
• Causal relationship to study drug 
• 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: 
• Confirming the seriousness assessment of all reported AEs and SAEs 
• Confirming the causal relationship between reported AEs/SAEs and the investigational 
product 
• Assessment of SAEs for expectedness 
The Sponsor will continuously assess the safety of the investigational product throughout the 
study. 


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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 
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: 
• Subject identification, Investigator name, and site number 
• SAE information: event term, onset date, severity, and causal relationship 
• 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) 
• A summary of relevant test results, pertinent laboratory data, and any other relevant 
medical history 
• The date of study drug administration (NOTE: as this is a double-blind study, SAERs 
should not indicate specific study drug assignments) 
• Indicate if the study drug was discontinued (i.e., if the second single dose is not 
administered to subjects in Cohorts 2A, 2B, 3A, or 3B) 
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 case report form (CRF) 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 adverse event 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. 


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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. 
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 Section 11.4.1 and 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, 


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“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. 
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: 
• Death 
• A life-threatening AE – see definition above 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• A congenital anomaly/birth defect in the offspring of a subject who received study drug 
• Is a suspected transmission of any infectious agent via a medicinal product 
• 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”: 
• 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. 


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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: 
• 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 
• 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, in order 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 8). 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 8: 
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. 
 


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11.5.2. 
Severity 
The Investigator will use the grading scale in Table 9 to describe the intensity of the AE 
following general categorical descriptors outlined in the DAIDS table for Grading the Severity of 
Adult and Pediatric Adverse Events (DAIDS 2017).  
Table 9: 
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. 
11.5.3. 
Serious Adverse Event 
Any adverse experience occurring at any dose of study medication that occurs during time 
periods indicated below are considered serious if they result in any of the outcomes listed in 
Section 11.4.4.  
Cohort 
SAE monitoring period from signing of Informed Consent Form: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
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. 


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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 attained 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: 
• The pregnancy should be reported to the Sponsor within 24 hours of the subject notifying 
the Investigator using the applicable Pregnancy Report Form. 
• 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. 
• 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, route (IM 
or SQ), and study drug (CD388 Injection or placebo). Listings of individual subject data will also 
be produced. 
Safety, PK, and pharmacodynamics will be summarized using descriptive statistics. There will 
be no formal hypothesis testing.  
12.1. 
Analysis Populations 
Analysis populations are: 
• Safety Population: all subjects who receive any amount of study drug 
• 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, and 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, severity, and route of administration. Treatment-emergent 
adverse events are defined as follows:  
Cohort 
TEAE is an AE that occurs during or after study drug administration: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B, 4B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
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. The TEAEs occurring after the first single 
dose and after the second single dose will be analyzed separately.  
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 


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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. 
12.4. 
Pharmacokinetic Analyses 
The PK parameters that will be assessed in the PK Analysis Population include:  
• 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-t) 
• area under the plasma concentration-time curve from time 0 extrapolated to infinity 
(AUC0-∞)  
CD388 concentration in the upper respiratory tract as determined from nasopharyngeal (NP) 
swabs collection will be summarized and reported separately. 
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. 
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 Metabolite Identification, 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. 
Metabolite identification and profiling, CD388 in urine and nasal wash, CD388 DAR 
distribution, CD388 glycoforms, pharmacogenomics, and exploratory biomarkers will be 
reported separately. 


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12.6. 
Interim Analysis 
Three blinded interim analyses of selected safety and PK data, one for the first dose level, 
another for the second dose level, and a third at the time when the 900 mg cohort completes 
Day 30. These interim analyses are for internal decision making or health authority interaction. 
Study team members involved in day-to-day trial related activities will not have access to interim 
analysis data which might unblind them at the subject level. Unblinding at treatment/group level 
is permitted as needed to enable the analysis. 
12.7. 
Determination of Study Sample Size 
Up to 77 subjects will be enrolled in this study, with approximately 56 of these subjects expected 
to receive CD388 Injection. The number of subjects was selected to allow sufficient evaluation 
of safety and tolerability, and PK, and is consistent with standards of practice for first-in-human 
(FIH) studies. 
12.8. 
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. 
12.9. 
Subject Disposition 
Enrollment and discontinuations from the study will be summarized, including the reasons for 
discontinuation. 
12.10. 
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 informed consent form (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, GCPs, 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: 
• Laboratory findings, clinical data, and all special test results from screening throughout 
the study  
• eCRFs (including data queries) properly completed by appropriate study personnel, 
signed and dated by the Investigator 


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• Copies of complete drug accountability records (drug inventory log and an inventory 
of returned or destroyed clinical material) 
• Copies of protocol amendments and IRB/IEC approval and notification, if appropriate 
• 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: 
• Rights and well-being of the human subjects are protected. 
• The reported study data are accurate, complete, and verifiable from source documents. 
• The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), with GCP, and with the applicable regulatory requirements. 
• 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: 
• Ensure subject safety 
• Assure compliance to study protocol procedures, regulatory requirements, and SOPs 
• 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 21 August 2021. 
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 21 August 2021. 
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 07 August 2021. 
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 21 August 2021. 
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 
11 November 2021. 
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: 
• Abstinence from heterosexual intercourse 
• Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth 
control products, transdermal patch) 
• Intrauterine device (with or without hormones) 
• 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 
≥120 bpm 
>220 msec 
≥120 msec 
- 
Borderline prolonged QT (males) 
- 
- 
- 
450 msec to ≤480 msec 
Borderline prolonged QT (females) 
  
  
  
470 msec to ≤480 msec 
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 to ≤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 
≤45 bpm 
≤50 mmHg 
≤90 mmHg 
Grade 1 or mild 
- 
>90 mmHg to <100 mmHg 
>140 mmHg to <160 mmHg 
Grade 2 or moderate 
- 
≥100 mmHg to <110 mmHg 
≥160 mmHg to <180 mmHg 
Grade 3 or severe 
- 
≥110 mmHg 
≥180 mmHg 
Abnormally high 
≥120 bpm 
- 
- 
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) 
≥38.6 to <39.3°C  
(≥101.5 to <102.7°F) 
≥39.3 to <40.0°C  
(≥102.7 to <104.0°F) 
≥40.0°C 
(≥104.0°F) 
a. Non-axillary temperatures only. 
 
For tachypnea and hypoxia, refer to the grading scale in Table 9. 


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CD388 Injection 
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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 
oxygen as well. Inhaled β2-agonists, such as albuterol, might be useful for bronchospasm 
refractory to epinephrine. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 77 of 85 
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. Glucagon for persistent hypotension in subjects taking β-blocker: Theoretically, there 
are multiple mechanisms by which β-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 bronchospasm by activating adenylate cyclase independent of the β-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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Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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Page 78 of 85 
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 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: AST, 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. 
• Subjects may continue the intake of study drug(s) (at the Investigator’s discretion). 
• An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
• 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.IM.SQ.1.01 
CD388 Injection 
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• Digital pictures should be taken within 24 hours after the onset of the rash. 
• 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. 
• Cetirizine, levocetirizine, topical corticosteroids, or antipruritic agents may be prescribed. 
• 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. 
• 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. 
• An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
• 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. 
• Digital pictures should be taken within 24 hours after the onset of the rash. 
• 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. 
• 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. 
• Cetirizine, levocetirizine, topical corticosteroids, or antipruritic agents may be prescribed. 


Cidara Therapeutics, Inc. 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 80 of 85 
• 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: 
• 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 ULN, subjects should be followed weekly with 
repeated local lab assessments and digital pictures until resolution of the AST/ALT 
abnormalities. 
• 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: 
• vesiculation, moist desquamation, or ulceration OR 
• cutaneous event with one of the following (revised by the Sponsor): 
− elevations in AST/ALT more than 2× baseline value and ≥5 × ULN 
− fever >38°C or 100°F 
− eosinophils >1000/mm3 
− serum sickness-like reaction 
A Grade 4 rash is defined as: 
• exfoliative dermatitis OR 
• a generalized rash with mucous membrane involvement OR 
• erythema multiforme OR 
• Stevens-Johnson Syndrome OR 
• rash associated with necrosis requiring surgery 


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Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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Page 81 of 85 
• 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. 
• An unscheduled visit for initial rash evaluation (day 1 of the rash) is required. 
• 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. 
• 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. 
• 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. 
• 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. 
• Appropriate management should be undertaken and subjects should be followed until 
resolution of the rash. 
• 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: 
• 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 >2× baseline value, and/or ≥5 × 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. 
• 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. 
• 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. 
• 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 >2× baseline value and/or ≥5 × 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. 


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Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
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Page 82 of 85 
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.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 83 of 85 
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. 
Rash Day 
Grade 1 Rash 
Grade 2 Rash 
Grade 3 or 4 Rash 
Rash day 1 a 
• Study drug(s) MAY 
be CONTINUED. 
• Unscheduled visit 
for initial rash 
evaluation 
REQUIRED. 
• Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
• Digital pictures 
REQUIRED 
(within 24 h). 
• Referral to 
dermatologist 
ONLY IF rash 
diagnosis uncertain 
(within 24 h). 
• 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. 
• Unscheduled visit for initial rash 
evaluation REQUIRED. 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• Digital pictures REQUIRED 
(within 24 h). 
• Referral to dermatologist 
REQUIRED (within 24 h). 
• Biopsy IF ADVISED by 
dermatologist (within 24 h). 
• Study drug(s) MUST be 
permanently DISCONTINUED. 
Rechallenge is NOT ALLOWED. 
• Unscheduled visit for initial rash 
evaluation REQUIRED. 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• Digital pictures REQUIRED 
(within 24 h). 
• Referral to dermatologist 
REQUIRED (within 24 h). 
• Biopsy REQUIRED (within 24 h). 
Rash day 2 
• Follow-up visit 
REQUIRED. 
• Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
• Digital pictures 
REQUIRED. 
• Follow-up visit REQUIRED. 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• Digital pictures REQUIRED. 
• Follow-up visit REQUIRED. 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• Digital pictures REQUIRED. 
Rash day 3 
No Rash follow-up visit 
required c 
No Rash follow-up visit required c 
• Follow-up visit REQUIRED. 
• Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2× baseline value, AND/OR 
5 × 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 
• Follow-up visit REQUIRED. 
• Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2× baseline value, AND/OR 
5 × ULN, AND/OR in case of rash 
progression. 


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Protocol CD388.IM.SQ.1.01 
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Amendment 2 
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Rash Day 
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 
• Follow-up visit REQUIRED.  
• Assessment of safety blood sample 
by local laboratory and digital 
pictures REQUIRED only if on 
days 1 and/or 2 of rash AST/ALT 
>2× baseline value, AND/OR 
5 × 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 
• Follow-up visit REQUIRED. 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• 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 
• Follow-up visit 
REQUIRED c 
• Assessment of 
safety blood sample 
by local laboratory 
REQUIRED. 
• Digital pictures 
REQUIRED. 
• Follow-up visit REQUIRED c 
• Assessment of safety blood sample 
by local laboratory REQUIRED. 
• 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: 
With AST/ALT increase ≤2× baseline 
value OR AST/ALT increase 
<5 × ULN: c 
• Weekly assessment of safety blood 
sample by local laboratory 
REQUIRED until resolution of 
AST/ALT abnormalities. 
• Weekly digital pictures REQUIRED 
until resolution of AST/ALT 
abnormalities. 
Without AST/ALT increase: further 
visits at the Investigator’s discretion. c 
• Weekly follow-up visits 
REQUIRED until resolution of 
Grade 3–4 rash to Grade ≤2 
(further follow-up visits according 
to Grade 1 or Grade 2 rash 
instructions) 
• 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 >2× baseline value, 
AND/OR 5 × 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.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
Page 85 of 85 
APPENDIX 6. INVESTIGATOR SIGNATURE 
I have read and understand Protocol CD388.IM.SQ.1.01 and I agree to the following: 
• 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 
• To comply with procedures for data recording and reporting 
• To permit monitoring, auditing, and inspection by the Sponsor, its designated 
representatives, and regulatory authorities  
• 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: 
 
 

SAP_001.pdf: 
Statistical Analysis Plan 
 
 
Title: 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single 
Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and 
Pharmacokinetics of CD388 Intramuscular or Subcutaneous 
Administration in Healthy Subjects 
NCT Number: 
NCT05285137 
Document Date: 
20 DEC 2023 
 


 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 1 of 125 
  
 
STATISTICAL ANALYSIS PLAN 
 
 
For: 
Cidara Therapeutics, Inc. 
 
PROTOCOL No. CD388.IM.SQ.1.01 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single Dose, Dose-Escalation Study to 
Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous 
Administration in Healthy Subjects 
Altasciences Project No. CID-P1-144 
 
Prepared by: 
Altasciences Company Inc. 
575 Armand-Frappier Boulevard 
Laval, Quebec 
Canada, H7V 4B3 
 
 
Version: Final Amendment 3.0 
Date: 2023-12-20 
 


 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 2 of 125 
  
STATISTICAL ANALYSIS PLAN AND TFL SHELLS APPROVAL 
We have carefully read this statistical analysis plan and the TFL shells appendix and agree it contains 
the necessary information required to handle the statistical analysis of study data. 
 
 
 
 
 
Haleh Aghamolaey 
Biostatistician II 
 
Date  
 
 
 
 
 
 
Dinh Bui 
PK Scientist II 
 
Date  
 
On behalf of the Sponsor: 
 
 
 
 
 
 
Ozlem Equils, MD, FAAP 
Senior Medical Director 
 
Date  
 
20-Dec-2023
20-Dec-2023
20-Dec-2023


 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 3 of 125 
  
VERSION CONTROL 
Version 
Date 
Author 
Description of Changes 
1.0 
2022-06-08 
Riddhi Thakkar/ 
Blake Scadden 
Not applicable 
1.1 
2023-04-05 
Riddhi Thakkar/ 
Blake Scadden 
SAP is being updated due to the protocol 
amendment 2.0 (07-Feb-2023) which 
added a new cohort 4B for SQ route.  All 
impacted sections are updated. 
1.2 
2023-07-12 
Logan Kowallis 
Added relative bioavailability model. 
2.0 
2023-07-31 
Anita Shanker 
Changes described in 1.1 & 1.2 
3.0 
2023-12-20 
Haleh Aghamolaey 
SAP is being amended to align the normal 
reference and PCS ranges with the lab 
used 
for 
the 
study 
and 
protocol 
parameters.  The full complement of 
normal reference ranges is listed in 
APPENDIX 
D. 
This 
version 
also 
addresses administrative changes.  
 
 


 
 
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TABLE OF CONTENTS 
STATISTICAL ANALYSIS PLAN AND TFL SHELLS APPROVAL ........................................ 2 
VERSION CONTROL .................................................................................................................... 3 
TABLE OF CONTENTS ................................................................................................................ 4 
TABLE OF TABLES ...................................................................................................................... 6 
ABBREVIATIONS ......................................................................................................................... 7 
1 
INTRODUCTION ................................................................................................................. 9 
2 
STUDY OBJECTIVES ........................................................................................................ 10 
3 
STUDY DESIGN ................................................................................................................. 13 
3.1 
General Description ........................................................................................................ 13 
3.2 
Investigational Product .................................................................................................... 14 
3.3 
Study Procedures ............................................................................................................. 14 
3.4 
Randomization and Unblinding Procedures .................................................................... 14 
4 
ANALYSIS POPULATIONS ............................................................................................. 15 
5 
STUDY SUBJECTS ............................................................................................................ 16 
5.1 
Disposition ...................................................................................................................... 16 
5.2 
Protocol Deviations ......................................................................................................... 16 
6 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS .............................. 18 
7 
PHARMACOKINETIC ANALYSIS .................................................................................. 19 
7.1 
Missing Values ................................................................................................................ 19 
7.2 
Measurements Below the Lower Limit of Quantitation ................................................. 19 
7.3 
Actual Time ..................................................................................................................... 19 
7.4 
Non-Compartmental Analysis ......................................................................................... 19 
7.5 
Statistical Methodology .................................................................................................. 21 
7.5.1 
Summary Statistics ................................................................................................ 21 
7.5.2 
Statistical Analysis ................................................................................................ 21 
8 
SAFETY ANALYSIS .......................................................................................................... 21 
8.1 
Adverse Events ................................................................................................................ 25 
8.2 
Clinical Laboratory Evaluations ..................................................................................... 25 
8.3 
Vital Signs ....................................................................................................................... 28 
8.4 
Physical Examination Findings ....................................................................................... 28 
8.5 
12-Lead ECG Analysis ................................................................................................... 28 
8.6 
Reactogenicity/Injection Site Inspection ......................................................................... 29 


 
 
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9 
pharmacogenomics, biomarker and Anti-drug Antibodies evaluations ............................... 30 
10 
DATA HANDLING AND PRESENTATION .................................................................... 30 
10.1 Safety Analysis Presentation ........................................................................................... 30 
10.2 Pharmacokinetic Analysis Presentation .......................................................................... 31 
10.3 Analysis Timepoints ........................................................................................................ 31 
11 
INTERIM ANALYSES AND DATA SAFETY MONITORING ...................................... 32 
12 
GENERAL INFORMATION RELATED TO DATA PRESENTATIONS ....................... 32 
APPENDIX A 
SCHEDULE OF EVENTS, First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, 
and 3B 
34 
APPENDIX B 
SCHEDULE OF EVENTS, Second Single Dose, Cohorts 2A, 2B, 3A, & 3B37 
APPENDIX C 
SCHEDULEOF EVENTS, Single Dose, Cohort 4B ................................... 39 
APPENDIX D 
LABORATORY NORMAL REFERENCE RANGES ............................... 42 
Hematology ................................................................................................................................... 42 
Serum Chemistry ........................................................................................................................... 43 
Lipids 
46 
Coagulation .................................................................................................................................... 47 
COMPLEMENT ACTIVATION .................................................................................................. 47 
Urinalysis 48 
SEROLOGY .................................................................................................................................. 49 
OTHER 
49 


 
 
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TABLE OF TABLES 
Table 1: 
Objectives and Related Endpoints ................................................................................... 10 
Table 2: 
Study Cohorts .................................................................................................................. 13 
Table 3: 
Data Presentations for Study Subject Information .......................................................... 16 
Table 4: 
Data Presentations for Demographic and Other Baseline Characteristics ...................... 18 
Table 5:  
Pharmacokinetic Parameters of CD388 in Plasma .......................................................... 20 
Table 6: 
Data Presentations for Safety Assessment....................................................................... 22 
Table 7: 
Clinical Laboratory Evaluations ...................................................................................... 25 
Table 8:  
PCS Values for Hematology............................................................................................ 26 
Table 9:  
PCS Values for Serum Chemistry ................................................................................... 27 
Table 10          PCS Values for Lipids ..................................................................................................... 27 
Table 11          PCS Values for Coagulation ............................................................................................ 27 
Table 12          PCS Values for Urinalysis ............................................................................................... 28 
Table 13:         PCS Values for Vital Signs ............................................................................................. 28 
 


 
 
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ABBREVIATIONS 
ADA 
Anti-Drug Antibodies 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
ATC 
Anatomical Therapeutic Chemical 
BMI 
Body Mass Index 
CI 
Confidence Interval 
CRF 
Case Report Form 
CRU 
Clinical Research Unit 
CSF 
Cerebrospinal Fluid 
CSR 
Clinical Study Report 
CV% 
Coefficient of Variability 
DAR 
Drug-Antibody Ratio 
DMP 
Data Management Plan 
DSMB 
Data Safety Monitoring Board 
DTS 
Deviation Tracking System  
ECG 
Electrocardiogram 
FIH 
First-In-Human 
EOS 
End of Study 
ET 
Early Termination 
GMR 
Geometric Mean Ratio 
ICF 
Informed Consent Form 
ICH 
International conference on council for harmonisation 
IM 
Intramuscular 
IP 
Investigational Product 
LN 
Natural Log 
LSMEAN 
Least Squares Mean 
MEDDRA 
Medical Dictionary for Regulatory Activities 
NCA 
Non-Compartmental Analysis 
NP 
Nasopharyngeal 
PCS 
Potentially Clinically Significant 
PK 
Pharmacokinetic(s) 
PT 
Preferred Term 
SAD 
Single Ascending Dose  
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SQ 
Subcutaneous 


 
 
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TEAE 
Treatment-emergent Adverse Event 
TFLS 
Tables, Figures, and Listings 
WHO-DD 
World Health Organization Drug Dictionary 
 
 
 


 
 
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1 
INTRODUCTION 
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 No. CD388.IM.SQ.1.01.  
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 2 dated 2023-
02-07. 
 
 


 
 
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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 determine the safety and 
tolerability profile of CD388 
Injection when dosed either by 
intramuscular (IM) or 
subcutaneous (SQ) 
administration as a single dose 
to healthy adult subjects. 
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. 
Refer to Section 8 
Secondary 
• To determine the plasma 
pharmacokinetic (PK) profile of 
CD388 Injection when dosed 
either by IM or SQ 
administration following a 
single dose and a repeated 
single dose to healthy adult 
subjects. 
• 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-t), 
area under the plasma 
concentration-time curve from 
time 0 extrapolated to infinity 
(AUC0-∞). 
Refer to Section 7 


 
 
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Objective 
Endpoint 
Analysis 
• To determine the safety and 
tolerability profile of CD388 
Injection when dosed either by 
IM or SQ administration as a 
repeated single dose (after 
washout of 3 months or 5 
effective half-lives from the first 
dose; whichever is longer) to 
healthy adult subjects. 
• Incidence and severity of 
TEAEs, including but not 
limited to AEs and SAEs 
(including systemic 
reactogenicity/injection site 
reactions and hypersensitivity 
reactions), AEs leading to study 
drug discontinuation and/or 
study withdrawal, vital signs, 
ECGs, and clinical laboratory 
tests (including hematology, 
coagulation, serum chemistry, 
and urinalysis), after a repeated 
single dose of CD388. 
Refer to Section 8 
Exploratory 
• To determine the PK profile of 
CD388 Injection in upper 
respiratory tract after IM or SQ 
administration as a single dose 
to healthy adult subjects. 
 
• 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-t). 
Refer to Section 7 
• To identify CD388 metabolites 
in plasma, CD388 and its 
metabolites in urine, and CD388 
drug-antibody ratio (DAR) 
distribution in plasma, and 
CD388 glycoforms in serum 
after IM or SQ administration to 
healthy adult subjects. 
• CD388 metabolites (e.g., free 
zanamivir, zanamivir dimers) in 
plasma and urine, CD388 in 
urine and nasal wash, CD388 
DAR distribution in plasma, and 
CD388 glycoforms in serum, to 
be reported separately. 
Refer to Section 7 
• To evaluate biomarkers that 
may be associated with AEs 
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 
• To evaluate CD388 
immunogenicity. 
• Anti-drug antibody titers in 
blood (plasma or serum). 
Refer to Section 9 
• To explore pharmacogenomics 
related to CD388. 
• Results of the analyses of 
pharmacogenomic samples, to 
be reported separately. 
Refer to Section 9 


 
 
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Objective 
Endpoint 
Analysis 
• To explore the effects on 
cardiac safety in subjects 
administered CD388 Injection. 
• 12-lead ECG and Holter 
monitoring parameters. 
Refer to Section 8 
• To explore the effect of CD388 
injection on the occurrence of 
influenza-like illness (during flu 
season). 
• Influenza-like illness reporting 
during the outpatient follow-up 
period. 
Refer to Section 8 
 
 
 


 
 
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3 
STUDY DESIGN  
3.1 
General Description 
This is a first-in-human (FIH), Phase 1, single-center, prospective, randomized, double-blind study of 
ascending single doses of CD388 Injection administered IM or SQ to healthy adult subjects followed 
by another single dose of CD388 Injection administered by the same route 3 months or 5 effective half-
lives, whichever is longer, after the first dose in the middle and high dose groups (dosing may be 
adjusted for tolerability). The goals are to assess safety, tolerability, immunogenicity (anti-drug 
antibodies [ADA]), and PK of CD388. 
Dose levels of CD388 to be assessed will follow an ascending single dose design with the starting dose 
based on findings from 3-month rat and monkey toxicology studies. Within each route (IM and SQ 
dose, route assignment is unblinded), subjects will be randomized to receive a single dose of CD388 
Injection or saline placebo (treatment assignment is blinded) according to the design. It should be noted 
that each cohort will be divided into 2 groups identified as “sentinel” groups (randomized 1:1) and 
“main” groups (randomized 7:2): 
• Low dose level: Cohort 1A (IM) and Cohort 1B (SQ) – each route n = 2 sentinel and n = 9 main 
• Mid dose level: Cohort 2A (IM) and Cohort 2B (SQ) – each route n = 2 sentinel and n = 9 main 
• High dose level: Cohort 3A (IM) and Cohort 3B (SQ) – each route n = 2 sentinel and n = 9 main 
• Highest dose level: Cohort 4B (SQ) – n = 2 sentinel and n = 9 main 
For each route, the sentinel or first group of 2 subjects (1 CD388: 1 placebo) at a dose level will be 
administered blinded study drug and closely monitored for safety for at least 1 week. If no drug-related 
SAEs or drug-related Grade ≥3 AEs have occurred, the subjects in the corresponding main group may 
be dosed within 24 hours. The observation duration may be adjusted for the sentinel groups in Cohorts 
2A, 2B, 3A, 3B, and 4B based on data from previous cohorts. 
Subjects in Cohort 4B will receive a single dose of CD388 or placebo. Subjects in Cohorts 2A and 2B 
and Cohorts 3A and 3B will receive a second single dose of CD388 Injection or placebo after washout 
of 3 months or 5 effective half-lives, whichever is longer, after the first dose if it is determined that the 
safety and tolerability of the first dose is acceptable upon review of the cumulative safety data. 
Immediately prior to the second single dose, within each dose and route, any dropouts in the sentinel 
groups will be randomly replaced with subjects from the main groups, retaining their original treatment 
assignment (i.e., subjects assigned to placebo will remain placebo, and subjects assigned to CD388 will 
remain CD388; this may require unblinded personnel to oversee).  
All subjects will be admitted to the clinical research unit (CRU) for observation and safety assessments 
from Day -1 (check-in) to Day 30. 
Table 2: Study Cohorts 
Dose (mg)  
Number of Subjects (N = 77) 
Intramuscular (IM) 
Subcutaneous (SQ) 
Cohort 
CD388 
(n = 24) 
Placebo 
(n = 9) 
Cohort 
CD388 
(n = 32) 
Placebo 
(n = 12) 
50 
Cohort 1A (sentinel) 
1 
1 
Cohort 1B (sentinel) 
1 
1 
50 
Cohort 1A (main) 
7 
2 
Cohort 1B (main) 
7 
2 
150 
Cohort 2A (sentinel) 
1 
1 
Cohort 2B (sentinel) 
1 
1 


 
 
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150 
Cohort 2A (main) 
7 
2 
Cohort 2B (main) 
7 
2 
450 
Cohort 3A (sentinel) 
1 
1 
Cohort 3B (sentinel) 
1 
1 
450 
Cohort 3A (main) 
7 
2 
Cohort 3B (main) 
7 
2 
900 
NA 
NA 
NA 
Cohort 4B (sentinel) 
1 
1 
900 
NA 
NA 
NA 
Cohort 4B (main) 
7 
2 
NA= Not Applicable 
Note: Immediately prior to the second single dose, within each dose and route, any dropouts in the sentinel groups will be randomly 
replaced with subjects from the main groups, retaining their original treatment assignment (i.e., subjects assigned to placebo will remain 
placebo, and subjects assigned to CD388 will remain CD388). 
3.2 
Investigational Product 
The investigational product (IP) CD388 will be provided by the Sponsor.  The placebo, normal saline, 
will be sourced by the site. 
3.3 
Study Procedures 
For complete details on the study assessments to be performed for each study period, refer to 
APPENDIX A for Cohort 1A to 3B and APPENDIX B for Cohort 2A to 3B.  
3.4 
Randomization and Unblinding Procedures 
After informed consent has been obtained, subjects will be screened for study eligibility before 
randomization.  
Within each route (IM and SQ dose, route assignment is unblinded), subjects will be randomized to 
receive a single dose of CD388 Injection or saline placebo (study drug assignment is blinded). The 
study site’s pharmacist (or pharmacist designee) will obtain the study drug assignment by a manual 
paper transaction. A subject is considered randomized when the randomization transaction is recorded 
in the subject’s source documents. 
All 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 pharmacy personnel, pharmacy monitor, and 
unblinded Sponsor personnel (such as Data Review Committee, clinical supply manager, bioanalytical, 
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). 


 
 
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4 
ANALYSIS POPULATIONS  
The following populations will be defined: 
• Enrolled Population: All subjects who provide informed consent and are randomized. 
• Safety Population: The safety population will include all randomized subjects who receive any 
amount of study drug. 
• Pharmacokinetic Population: The PK population will include all randomized subjects who 
have received at least a portion of 1 dose of CD388 and have at least 1 evaluable postdose 
concentration value. Subjects administered matching placebo will not be included in the PK 
population. 
Pharmacokinetic Completer Population: [Dose Groups 2A, 2B, 3A, and 3B only] The PK 
population will include all randomized subjects who have received 2 single doses of CD388 and 
obtained PK samples at all visits.  
 
 
 
 
 


 
 
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5 
STUDY SUBJECTS 
Disposition data, analysis population information and protocol deviations will be summarized by 
injection route (IM or SQ), CD388 dose, and pooled placebo and listed by injection route (IM or SQ), 
CD388 dose and placebo as described in Table 3.   
Table 3: Data Presentations for Study Subject Information 
Data 
Variables 
Presentation 
Disposition and analysis 
populations 
Subject, completion status (i.e., 
completed or withdrawn from the 
study), reason for withdrawal from the 
study, analysis population 
determination 
Listings: 
• Disposition, 
• Randomization, 
• Analysis populations 
Summary table including: 
• N of subjects randomized,  
• N and % of subjects who 
completed the study,  
• N and % of subjects 
discontinued from the 
study by primary reason 
for discontinuation  
• N and % of subjects 
discontinued from the 
treatment by primary 
reason for discontinuation   
N and % of subjects included in 
each of the analysis populations.  
Protocol deviations 
Protocol deviations 
Listings: 
• Protocol deviations, 
• Pharmacokinetic (PK) 
sample collection time 
deviations 
Summary table: 
• 
N and % of subjects 
with any major  
deviation 
5.1 
Disposition 
Subject disposition will be summarized for all subjects screened and randomized.  
The percentages will be calculated using the number of subjects in each cohort and study drug group as 
the denominator.  
5.2 
Protocol Deviations 
Deviations identified at the site will be collected in the clinic deviation tracking system (DTS) and 
presented in a protocol deviation listing. Protocol deviations will be listed for the safety population. 
The number and percentage of subjects with any major deviation will be presented.  


 
 
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For PK sampling time deviations, information will be derived programmatically and presented in a 
separate listing.  
 
 


 
 
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6 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Unless otherwise specified, all available data will be listed for the safety population as detailed in 
Table 4. Summary tables for demographics and other baseline characteristics by injection route (IM or 
SQ), CD388 dose, and pooled placebo will be presented for safety and PK populations.   
Table 4: Data Presentations for Demographic and Other Baseline Characteristics 
Data 
Variables 
Presentation 
Demographic and other 
baseline characteristics 
Sex, age, ethnicity, race, height (cm), 
weight (kg) and body mass index 
(BMI, kg/m2) 
Listing and summary tables  
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 
and concomitant medications 
(including vaccines, prescription 
medications, nonprescription 
medications, dietary supplements, 
vitamins, or herbal medications) 
Listing 
Note: includes coded terms 
(anatomic therapeutic chemical 
[ATC] level 4 and preferred 
name)  
Demography and baseline characteristics will be summarized using descriptive statistics.  
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 24.1 and listed by 
subject. 
Prior medication will be coded using the World Health Organization Drug Dictionary Global B3 Sept 
1, 2021, and will be listed by subject. 
 
 
 


 
 
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7 
PHARMACOKINETIC ANALYSIS 
The PK analysis will be carried out according to Altasciences Standard Operating Procedures (SOPs). 
7.1 
Missing Values 
Except for predose samples (prior to the first administration), 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 considered missing in the dataset, and no imputation will be done. Predose samples, 
prior to the first administration, will be imputed with zero. 
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 and will be excluded from descriptive 
statistics but will be presented in listings. 
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).  
7.2 
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. Descriptive statistics will not be 
determined for time points with more than 1/3rd of samples missing.   
7.3 
Actual Time 
The NCA will be based on the actual sampling times, except for the pre-first dose predose samples, 
which will always be reported as zero, regardless of time deviations, provided that they were collected 
prior to dosing. Available time points before second dose and after first dose may be used as predose 
time points in some analyses. 
The individual concentration/time profiles will be presented using actual sampling times whereas the 
mean concentration/time profiles and tables presenting summary statistics of concentration time series 
will be presented using nominal sampling times. 
Actual times will be listed in the report. 
7.4 
Non-Compartmental Analysis  
The following configuration for the NCA of CD388 in plasma or nasopharyngeal concentrations (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 (λz) calculation: 
Best fit method for λz Linear-Log regression 
Reasons for excluding PK parameters will include the following: 
• AUC: AUC parameters will not be estimated if less than 3 consecutive measurable concentrations 
are observed. 


 
 
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PK parameters requiring λz estimation (e.g., and t1/2) will be set to Not Reported (NR) in the Tables and 
Listings if they meet the following: 
• R2 < 0.8 
The PK parameters for CD388 are presented in Table 5. 
Table 5:  
Pharmacokinetic Parameters of CD388 in Plasma 
PK Parameter 
Definition 
Plasma Concentrations 
Cmax 
Maximum observed concentration 
tmax 
Time of maximum observed concentration; if it occurs at more than one time 
point, Tmax is defined as the first time point with this value 
AUC0-t 
Area under the concentration time curve from time 0 (dose administration) to the 
time of last quantifiable concentration (tlast) 
AUC0-∞ 
Area under the concentration time curve extrapolated to infinity, calculated as 
AUC0-t + CLQC/λZ, where CLQC is the measured concentration at time tlast and λZ is 
the apparent elimination rate constant, estimated by linear regression of the 
terminal linear portion of the log concentration versus time curve 
t1/2 
Terminal elimination half-life, calculated as ln(2)/λZ 
CL/F 
Apparent total clearance, calculated as Dose/AUC0-∞  
Vz/F 
Apparent volume of distribution, calculated as Dose/λZ * AUC0-∞  
Nasopharyngeal Concentrations 
Cmax 
Maximum observed concentration 
tmax 
Time of maximum observed concentration 
AUC0-t 
Area under the concentration time curve from time 0 (dose administration) to the 
time of last quantifiable concentration (tlast) 
Plasma Concentrations 
The following plasma PK parameters will be used for PK calculation and presented in the listings only  
AUC%ext 
Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from tlast to 
infinity) 
R2 
Goodness of fit statistic for the terminal elimination phase 
Number of Points 
Number of data points in computing λZ 
λz Lower 
Lower limit on time for values included in the calculation of λz 
λz Upper 
Upper limit on time for values included in the calculation of λz 
λz 
Apparent elimination rate constant, estimated by linear regression of the terminal 
linear portion of the log concentration versus time curve 
tlast 
Time of last measurable observed concentration 


 
 
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7.5 
Statistical Methodology 
All tables, figures, and listings (TFLs), when appropriate, will be summarized by cohort and by injection 
route. 
7.5.1 Summary Statistics 
Summary statistics of the individual concentration data and derived parameters will be calculated for the 
PK population at each nominal time point and for all PK parameters. Concentration data will be 
summarized by group 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%. 
7.5.2 Statistical Analysis 
The natural logarithmic transformation of Cmax, AUC0-t, and AUC0-∞ will be used for all statistical 
inference. Individual ratios of untransformed parameter values will also be presented as part of the 
descriptive analysis.  
Pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) will be statistically analyzed using an Analysis 
of Variance (ANOVA) model by dose level. The fixed factors included in this model will be injection 
route (IM to SQ). The 90% confidence interval (CI) for the exponential of the difference in least squares 
means (LSmeans) between each comparison of interest (IM to SQ) will be calculated. 
Pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) will be statistically analyzed using an Analysis 
of Variance (ANOVA) model to assess relative bioavailability. Dose is the fixed factor. The 90% CI for 
the differences in LSmeans for each pairing of doses will be calculated and used to assess relative 
bioavailability. Injection route (IM and SQ) will be assessed in two separate models. 
Pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) for IM and SQ cohorts will also be assessed 
statistically for dose proportionality, using a power model: 
ln (PK parameter) = α + β • ln (Dose) + ε 
where α is the intercept, β is the slope and ε is the error term.  
A point estimate and corresponding 90% CI will be derived for the slope (β). 
Tmax will be analyzed descriptively. 
8 
SAFETY ANALYSIS 
Unless otherwise specified, all available data will be listed and summary tables for safety assessments 
will be presented by injection route (IM or SQ), CD388 dose, and pooled placebo for the safety 
population as detailed in Table 6.  
Continuous variables will be summarized (absolute values and change from baseline) using descriptive 
statistics. The TEAEs occurring after the first single dose and after the second single dose will be 
analyzed separately. 


 
 
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Table 6: 
Data Presentations for Safety Assessment 
Data 
Variables 
Presentation 
Adverse events 
Adverse event, description, 
date and time, severity, 
relationship to study drug, 
action taken with study drug, 
whether the AE caused the 
subject to discontinue from 
the study, study days, and 
outcome, Duration of AE, 
Date and time of onset, date, 
and time of resolution. 
Listings: 
• 
Reported AEs,  
• 
Serious Adverse Event (SAE) 
Summary 
Tables, 
including 
number 
and 
percentage of subjects experiencing:  
• 
Treatment-emergent adverse events (TEAEs),  
• 
TEAEs related to study drug  
• 
TEAEs by severity,  
• 
Serious TEAEs, 
• 
Influenza-like TEAEs (reported during the 
outpatient follow-up period), 
• 
Adverse Events of Special Interest (AESIs), 
• 
TEAEs leading to study withdrawal 
• 
TEAEs leading to study drug withdrawal 
(cohorts 2a, 2b, 3a, 3b ) 
• 
Overall summary will include: 
o At Least One TEAE 
o At Least One Drug-Related TEAE 
o Maximum Severity:  
➢ Mild,  
➢ Moderate   
➢ Severe 
➢ Life-threatening 
➢ Death 
o At Least One SAE 
o At Least One Drug-Related SAE 
o Death 
o AE leading to study drug withdrawal 
(Pooling placebo from cohorts 2a, 2b, 3a, 
3b )  
o AE leading to study withdrawal  
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)  


 
 
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Data 
Variables 
Presentation 
Extent of exposure 
Study drug administration 
dose, Route, units, date, time, 
Cohort 
Listing 
 
Clinical 
laboratory 
evaluations 
Laboratory results (refer to 
section 8.2 for parameters) 
Listings: 
• 
All laboratory values by category, 
• 
Subjects 
with 
a 
potentially 
clinically 
significant (PCS) laboratory value by category 
Summary Tables:  
• 
Laboratory values and change from baseline by 
visit. 
• 
Number and percentage of subjects with at 
least one post baseline laboratory value that is 
deemed PCS (as defined in Table 8, Table 9,  
• Table 10         PCS Values for Lipids 
• 
Laboratory 
Parameter 
, 
Unit 
PCS Range 
Triglycerides, 
mg/dl 
> 500 
Low Density 
Lipoprotein (LDL), 
mg/dl 
> or = 190 
Cholesterol, Total, 
mg/dl 
> = or 300 
 
• Table 11         PCS Values for Coagulation 
Laboratory 
Parameter , Unit 
PCS Range 
Activated partial 
thromboplastin time, 
seconds 
> or = 1.66 x ULN 
Prothrombin, 
International 
normalized ratio 
(INR), Ratio  
> or = 1.5 x ULN 
Prothrombin Time, 
seconds 
> or = 1.25 x ULN 
 
Table 12          PCS Values for Urinalysis 


 
 
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Data 
Variables 
Presentation 
Laboratory 
Parameter 
PCS Range 
Bilirubin  
1+ 
Erythrocyte (/HPF) 
> or = 10 
Glucose 
2+ 
Ketones 
1+ 
Leukocyte Esterase 
1+ 
Nitrite 
1+ 
Occult Blood 
Trace 
Protein 
2+ 
 
• 
Table 10, Table11, Table 12) by category.  
• 
Number and percentage of subjects with a 
laboratory value that is deemed PCS, for each 
scheduled post baseline assessment time point 
Vital signs 
Blood 
pressure, 
pulse, 
respiration rate, and body 
temperature 
Listings: 
• 
All vital signs values,  
• 
PCS vital sign values 
Summary Tables:  
• 
Vital signs values and change from baseline by 
visit and timepoint. 
• 
Number and percentage of subjects with at 
least one post baseline PCS value will be 
summarized for the worst post baseline value. 
• 
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 
Listing: 
• 
All physical examination findings 
12-Lead 
Digital 
Electrocardiograms  
ECG 
interpretations 
and 
findings;  
Listings: 
• 
All ECGs,  
• 
Clinically significant ECGs, 
Summary Tables 
• 
ECGs parameters values and change from 
baseline by visit and timepoint. 
• 
Categorical QTCF analysis by Visit and 
timepoint. 
Reactogenicity/Injection 
Site Inspection 
Reactogenicity/Injection Site 
Inspection findings 
Listing 
Table 


 
 
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8.1 
Adverse Events 
Treatment-emergent adverse events (TEAEs) are AEs that are not present prior to the exposure to study 
drug or AEs that are already present that worsen in severity or frequency following exposure to study 
drug.  All summary tables (except where noted) will present TEAEs. If a subject has more than one 
TEAE with the same PT (after the same dose, if applicable), it is counted once in the summary tables at 
the strongest relationship to study drug and at the highest severity. 
All TEAEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 24.1. 
The listing and summaries will include coded SOC and PT. Events will be listed by study drug, subject, 
and AE onset date. Treatment-emergent Adverse Event duration (stop date/time - start date/time), 
management, concomitant laboratory, vitals, and clinical examination abnormalities will be included in 
the listing. 
8.2 
Clinical Laboratory Evaluations 
Laboratory data will be presented using units as reported by the clinical laboratory. Specific hematology, 
clinical chemistry, urinalysis, coagulation, and serology parameters are listed in Table 7. 
Table 7: 
Clinical Laboratory Evaluations 
Laboratory Test 
Category 
 
Specific Laboratory Tests 
Hematology: 
Hemoglobin 
Neutrophils (absolute) 
Hematocrit 
Monocytes 
Erythrocyte (red blood count [RBC]) count Eosinophils 
Quantitative platelet count 
Lymphocytes 
Total leukocyte (white blood cell 
[WBC]) count 
Basophils 
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 
Total bilirubin (if total bilirubin is ≥2 × 
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: 
Triglycerides 
Low Density Lipoproteins (LDL) 
Cholesterol, Total 
 
Coagulation: 
Activated partial thromboplastin time 
(aPTT) 
International 
normalized 
ratio 
for 
prothrombin time (INR/PT) 
Complement 
Activation: 
Complement C3, C4, CH50 
 


 
 
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Laboratory Test 
Category 
 
Specific Laboratory Tests 
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 
gonadotropin (β-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 
Other 
Drug (opioids, benzodiazepines, barbiturates, cocaine metabolites, cannabinoids, 
methamphetamines, phencyclidine, amphetamine, cotinine) and alcohol 
screen  
 
Values for continuous laboratory parameters (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, H) and whether the abnormal values are clinically 
significant or not and an indication of whether the value meets the PCS criterion. 
PCS values for laboratory parameters (as defined in Table 8, Table 9, Table 10, Table 11, Table 12 
below) will be listed by category. Normal reference ranges are presented in APPENDIX D. 
 
Table 8:  
PCS Values for Hematology 
Laboratory Parameter (Unit) 
PCS Range 
Absolute basophils, cells/uL 
> 400 
Absolute eosinophils, cells/uL 
> 800 
Absolute lymphocytes, cells/uL 
< 600 
Absolute monocytes, cells/uL 
< 10, > 2100 
Absolute neutrophils, cells/uL 
< or = 799, > 9000 
Erythrocytes, (million/uL) 
Male: < 3.8, > 6.4 
Female: < 3.3, > 5.5 


 
 
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Laboratory Parameter (Unit) 
PCS Range 
Hematocrit, % 
< 20.0, > 60.0 
Hemoglobin, g/dL 
Male: < 10 
Female: < 9.5 
Leukocytes, (thousands/uL) 
< 2.0. > 25.0 
Platelet count, thousands/uL 
< 100, > 700 
Table 9:  
PCS Values for Serum Chemistry 
Laboratory Parameter ,Unit 
PCS Range 
Alanine aminotransferase, U/L 
> or = 1.25 x ULN 
Albumin, g/dL 
< 3.0, > 6.0 
Alkaline phosphatase, U/L 
> or = 2.5 x ULN 
Asparate Aminotransferase, U/L 
> or = 1.25 x ULN 
Amylase, U/L 
> or = 1.5 x ULN 
Bilirubin total, mg/dL 
> or = 1.1 x ULN 
Blood urea nitrogen, mg/dL 
> 70 
Calcium, mg/dL 
< 7.8, > or = 12.4 
Carbon dioxide, mmol/L 
< 16, > 40 
Chloride, mmol/L 
< 65, > 130 
Creatinine, mg/dL 
> or = 1.1 x ULN 
Creatinine Clearance, Estimated, mL/min 
< 90 
Glucose, nonfasting, mg/dL 
< 54, > 160 
Lipase, U/L 
>  or = 1.5 x ULN 
Phosphorus, mg/dL 
< 2 
Potassium, mmol/L 
< 3 , > or = 6 
Protein total, g/dL 
< 3.0, > 9.0 
Sodium, mmol/L 
< 130, > or = 150 
 
Table 10         PCS Values for Lipids 
Laboratory Parameter , Unit 
PCS Range 
Triglycerides, mg/dl 
> 500 
Low Density Lipoprotein (LDL), mg/dl 
> or = 190 
Cholesterol, Total, mg/dl 
> = or 300 
 
Table 11         PCS Values for Coagulation 
Laboratory Parameter , Unit 
PCS Range 
Activated partial thromboplastin time, seconds 
> or = 1.66 x ULN 
Prothrombin, International normalized ratio (INR), 
Ratio  
> or = 1.5 x ULN 
Prothrombin Time, seconds 
> or = 1.25 x ULN 


 
 
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Table 12          PCS Values for Urinalysis 
Laboratory Parameter 
PCS Range 
Bilirubin  
1+ 
Erythrocyte (/HPF) 
> or = 10 
Glucose 
2+ 
Ketones 
1+ 
Leukocyte Esterase 
1+ 
Nitrite 
1+ 
Occult Blood 
Trace 
Protein 
2+ 
 
 
8.3 
Vital Signs 
Vital signs will include systolic and diastolic blood pressure, 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 13) will be listed by parameters. 
Table 13:         PCS Values for Vital Signs 
Parameter (Unit) 
PCS Range 
Systolic Blood Pressure (mmHg) 
<= 90, >= 140 
Diastolic Blood Pressure (mmHg) 
<= 60, >= 90 
Pulse Rate (beats/min) 
<= 50, >= 100 
Temperature (⁰C) 
<= 36, > 38 
Respiratory Rate (breaths/min) 
<= 12, >= 20 
 
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, 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 
12-Lead ECG Analysis 
12- Lead safety 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: 


 
 
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Absolute value > 450 msec and ≤ 480 msec 
Absolute value > 480 msec and ≤ 500 msec 
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 injection route (IM or 
SQ), CD388 dose, pooled placebo, time since last dose (days:hrs;min), resolution date and time and 
maximum intensity based on Table 8 of the protocol for severity assessments. Additionally, data 
listings will be provided.  
 


 
 
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9 
PHARMACOGENOMICS, BIOMARKER AND ANTI-DRUG ANTIBODIES 
EVALUATIONS 
Additional blood samples will be collected for pharmacogenomics and exploratory biomarker 
evaluation, and additional blood and urine samples will be collected for exploratory metabolite 
identification, to be reported separately. Analyses of lost DNA and biomarkers may be conducted at the 
Sponsor’s discretion and reported separately from the study report. After discharge from the CRU, 
additional sample collection for PK and ADA will be performed at specified time points after dosing. 
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. 
10 DATA HANDLING AND PRESENTATION 
All safety and statistical outputs will be generated using SAS software, version 9.4. All programs used 
to generate statistical analyses will be validated according to Altasciences’s SOPs). Draft tables, 
figures and listings will be provided in RTF format. 
10.1 Safety Analysis Presentation 
Generally, summaries will be presented by injection route (IM or SQ), CD388 dose, pooled placebo 
and where applicable, by visit and timepoint. Study days will be calculated relative to the study drug 
administration after the first single dose or second single dose wherever it is applicable.  
Study days will be included in adverse events and concomitant medication listings in addition to dates. 
Study days will be calculated relative to the first day of study drug administration (Day 1) derived as 
(event date - first day of study drug administration) +1 for events after the first day of dosing and 
(event date - first day of study drug administration) for events before the first day of dosing. 
The following general comments also apply to all statistical analyses and data presentations: 
• Duration variables will be calculated using the general formula: (end date - start date) +1. 
• 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 general, a value or 
lower and upper limit of normal range such as ‘<10’ or ‘≤5’ will be 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. 
In general, summary statistics for raw variables (i.e., variables measured at the study site or central 
laboratory) will be displayed as follows:  
• Minima and maxima will be displayed to the same number of decimal places as the raw data.  
• Means, medians, and quartiles will be displayed to 1 additional decimal place.  
• Standard deviations will be displayed to 2 additional decimal places.   
• Percentages will be displayed to 1 decimal place. Percentages between 0 and 0.1 (exclusive) 
will be displayed as ‘<0.1’.   
The numbers of decimal places for summary statistics of 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 
determined on a case-by-case basis.  In general:  


 
 
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• Minima and maxima will be displayed to the commonly used unit of precision for the 
parameter.  
• Means, medians, quartiles, and confidence limits will be displayed to 1 additional decimal 
place.  
• Standard deviations will be displayed to 2 additional decimal places.  
10.2 Pharmacokinetic Analysis Presentation 
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:  
• Concentration-related PK parameters (e.g., Cmax, AUCs) will be displayed with the same 
precision as the raw PK concentration data, 
• Apparent clearance (CL/F) and volume of distribution (Vz/F) will be reported to 3 significant 
figures, 
• Parameters associated with time (e.g., tmax, t1/2) will be displayed with 2 decimal places, 
• Percentages and ratios will be displayed with 2 decimal places, 
• Coefficient of determination (R2) and elimination rate constant (λz) 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.  
10.3 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 and for the second dose of cohorts 2 and 3 on dosing date with 
timepoint marked as “predose” will be considered as baseline for the second dose analysis tests. 
 
 
 


 
 
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11 INTERIM ANALYSES AND DATA SAFETY MONITORING 
Three blinded interim analyses of selected safety and PK data, one for the first dose level, another for 
the second dose level, and a third at the time when the 900 mg cohort completes Day 30. These interim 
analyses are for internal decision making or health authority interaction. Study team members involved 
in day-to-day trial related activities will not have access to interim analysis data which might unblind 
them at the subject level.  
12 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 Note to 
SAP. 


 
 
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APPENDIX A SCHEDULE OF EVENTS, First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B 
Day 
(Window) 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Informed consent 
X 
Inclusion/Exclusion criteria c 
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) 
X 
X d 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety ECG e 
X 
X 
X 
X 
X 
X 
Holter Monitor ECG f 
X 
X 
X 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
X 
X 
X g 
X 
X 
X 
X 
X 
X 
X 
X 
Lipids, coagulation, complement 
activation h 
X 
Virology screening (HBV, HCV, HIV) 
X 
Virology screening (SARS-CoV-2) 
X 
Serum/urine pregnancy test, FSH i 
X 
X 
X 
X 
X 
X 
X 
Drug/alcohol screen j 
X 
X 
Randomization 
X 
Dosing of study drug 
X 
Reactogenicity/injection site inspection k 
X 
X 
X 
PK sample collection l 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite identification 
and CD388 DAR distribution m 
X 
X 
X 
X 
X 
Samples for CD388 glycoforms n 
predose 
X 
X 
X 
X 
X 
X 
X 


 
 
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Day 
(Window) 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Pharmacogenomics blood sample o 
predose 
Exploratory biomarker samples 
predose 
X g 
Anti-drug antibodies 
predose 
X 
X 
X 
X 
X 
X 
Nasopharyngeal swab collection p 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
Assess and record AEs q 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/procedures 
review r 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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; OV = outpatient visit; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe 
acute respiratory syndrome coronavirus 2. 
Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B 
a. For subjects in Cohorts 1A and 1B: outpatient visits will occur at Day 45 (OV1), Day 60 (OV2), Day 90 (OV3), and Day 120 (OV4). 
For subjects in Cohorts 2A, 2B, 3A, and 3B, timing of outpatient visits will occur at Day 45 (OV1), ~2× t½ (OV2), ~3× t½ (OV3), and ~4× t½ (OV4), pending 
PK data from Cohorts 1A and 1B. If 2 half-lives have passed by OV2, the visit may be omitted. 
b. For subjects who discontinue study early, the OV4 procedures should be performed. 
c. For subjects in Cohorts 2A, 2B, 3A, and 3B, reconfirmation of inclusion and exclusion criteria (retesting of FSH not required) is to be completed at second 
single dose period’s CRU check-in and prior to the second single dose of CD388 Injection or placebo. 
d. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated. 
e. 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 and semi-recumbent when ECG is being conducted. 
f. For Cohorts 1A, 1B, 2A, 2B, 3B: Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG 
tracings, including all 12-leads and of 10 seconds duration, will be extracted in triplicate for 5-minute observation periods at 60, 45, and 30 minutes predose; 
and at 2, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours postdose (expected time to maximum concentration is 1 to 2 days after administration). The Holter monitor 
will be removed on Day 3. The Holter monitor may be removed once on Day 2 for up to 15 minutes for shower/bathing, at least 2 hours away from the next 
ECG timepoint (i.e., 30, 36, or 48 hours postdose). 
For Cohort 3A: Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG tracings, 
including all 12 leads and of 10 seconds duration, will be extracted in triplicate at prespecified time points for a 5-minute observation period starting from 
1 hour before dosing, then at 72, 76, 80, 84, 96, 102, 106, 110, 118, and 120 hours after administration of study drug, and stored in a digital format. The 
Holter monitor may be removed once on Day 5 for up to 15 minutes for shower/bathing, at least 1 hour away from the next ECG timepoint. The Holter 
monitor will be removed on Day 6. 


 
 
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Schedule of Events: First Single Dose, Cohorts 1A, 1B, 2A, 2B, 3A, and 3B (continued) 
g. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
h. 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). 
i. A sensitive serum pregnancy test (β‑human chorionic gonadotropin) is required at screening and OV4 for females of childbearing potential. 
FSH (if applicable to confirm postmenopausal status) is only required once. Urine pregnancy test may be performed at all other time points. 
j. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see in protocol Appendix 2). 
k. 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), with any abnormal findings reported as AE s. Reactions will be rated according to the scale provided in 
protocol Table 7. 
l. For Cohorts 1A, 1B, 2A, 2B, 3B: 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 Days 7, 9, 11, 14, 21, 30 
(each ±2 hour window). Postdose samples collected at outpatient CRU visits at OV1, OV2, OV3, and OV4 have the same windows (i.e., in ±days) as the 
visits. 
For Cohort 3A: Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 12 and 24 hours (±30 minute window); 48 hours 
(±1 hour window); 72, 84, 96, 108, 120 hours (each ±2 hour window); and Days 7, 9, 11, 14, 21, 30 (each ±2 hour window). Postdose samples collected at 
outpatient CRU visits at OV1, OV2, OV3, and OV4 have the same windows as the visits. 
m. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) and CD388 DAR distribution will be collected on Day 1 at 2 hours 
postdose, on Day 2 at 24 hours postdose, on Days 14 and 30, and at OV3. Urine samples for metabolite identification will be collected on Day 1 from 
0–12 hours and from 12–24 hours postdose, on Day 2 from 24–48 hours postdose, on Day 14 over a 24-hour period, and over a 24-hour period that starts on 
Day 29 and ends prior to CRU check-out on Day 30. 
n. Serum samples for CD388 glycoforms will be collected predose on Day 1 and once in the morning on Days 2, 7, 14, 21, and 30, and at the OV1 and OV3 
visits. 
o. 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. 
p. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. 
q. 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 4 months after the last dose of study drug, whichever is longer. 
r. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit. 
 
 
 


 
 
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APPENDIX B SCHEDULE OF EVENTS, Second Single Dose, Cohorts 2A, 2B, 3A, & 3B 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits a 
Day 
(Window) 
-1 
(±10) 
1 
2 
3-6 
7 
9 
11 
14 
21 
30 
OV1 
(±3) 
OV2 
(±5) 
OV3 
(±7) 
OV4 b 
(±14) 
Inclusion/Exclusion criteria c 
X 
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) 
X d 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety ECG e 
X 
X 
X 
X 
X 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
X 
X f 
X 
X 
X 
X 
X 
X 
X 
X 
Virology screening (HBV, HCV, HIV) 
X 
Virology screening (SARS-CoV-2) 
X 
Urine Pregnancy g 
X 
Drug/alcohol screen h 
X 
Dosing of Study Drug 
(Cohorts 2 and 3 only) 
X 
Reactogenicity/injection site inspection i 
X 
X 
X 
PK sample collection j 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite identification k 
X 
X 
X 
X 
X 
Exploratory biomarker samples 
predose 
X f 
Anti-drug antibodies 
predose 
X 
X 
X 
X 
X 
X 
Nasopharyngeal swab/nasal wash 
collection l 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
Assess and record AEs m 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/procedures 
review n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AEs = adverse events; BMI = body mass index; BP = blood pressure, CBC = complete blood count; COVID-19 = coronavirus disease 2019; CRU = clinical 
research unit; ECG = electrocardiogram; 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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Schedule of Events: Second Single Dose, Cohorts 2A, 2B, 3A, and 3B 
a. For subjects in Cohorts 2A, 2B, 3A, and 3B: outpatient visits will occur at Day 45 (OV1), Day 84 (OV2), Day 126 (OV3), and Day 168 (OV4). 
b. For subjects who discontinue study early, the Day 168 procedures should be performed. 
c. Reconfirmation of inclusion and exclusion criteria (retesting of FSH not required) is to be completed at CRU check-in on Day -1 and prior to the second 
single dose of CD388 Injection or placebo on Day 1. 
d. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as clinically 
indicated. 
e. 12-lead ECG is to be performed at CRU check-in on Day -1, predose (immediately prior to study drug administration on Day 1) and 6 hours postdose 
(±10 minutes), and as indicated in the Schedule. Subjects are to be resting and semi-recumbent when ECG is being conducted. 
f. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
g. Urine pregnancy test is required for females of childbearing potential at CRU check-in on Day -1. 
h. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see in protocol Appendix 2). 
i. 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), with any abnormal findings reported as AEs. Reactions will be rated according to the scale provided in 
protocol Table 7. 
j. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 24 hours (±30 minute window); 48 hours (±1 hour window); 72, 96, 
120, 144, 168 hours (each ±2 hour window); and Days 9, 10, 11, 12, 14, 21, 30 (each ±2 hour window). Postdose samples collected at outpatient CRU visits 
on Days 45, 60, 90, and 120 have the same windows (i.e., in ±days) as the visits. 
k. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) will be collected on Day 1 at 2 hours postdose, on Day 2 at 24 hours 
postdose, on Day 30, and on Day 90. Urine samples for metabolite identification will be collected on Day 1 from 0–48 hours, from 48–96 hours, and from 
96–144 hours postdose, on Day 14 over a 24-hour period, and over a 24-hour period that starts on Day 29 and ends prior to CRU check-out on Day 30. 
l. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. Nasal wash collection will occur at the time of 
Cmax as determined from the first single dose (approximately 144 hours after dosing). 
m. Adverse events (including influenza-like illness which will be tested for both COVID-19 and flu) will be collected for all subjects as indicated below: 
 
Cohort 
AE/SAE monitoring period from signing of Informed Consent Form: 
1A, 1B 
Through 4 months after the dose of study drug 
2A, 2B, 3A, 3B 
Through 205 days after the last dose of study drug (Day 206 ±10 days) 
Note: the final AE assessment will be conducted via a follow-up phone call to the subject. 
n. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit. 
 
 


 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
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APPENDIX C SCHEDULEOF EVENTS, Single Dose, Cohort 4B 
Day 
(Window) 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
45 
(±3) 
84 
(±5) 
126 
(±7) 
168 
(±14) 
206 a 
(±10) 
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) 
X 
X b 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety ECG c 
X 
X 
X 
X 
X 
X 
Holter Monitor ECG d 
X 
X 
X 
Laboratory evaluations (CBC 
with/platelets, serum chemistry, 
urinalysis) 
X 
X 
X 
X e 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Lipids, coagulation, complement 
activation f 
X 
Virology screening (HBV, HCV, 
HIV) 
X 
Virology screening (SARS-CoV-2) 
X 
Serum/urine pregnancy test, FSH g 
X 
X 
X 
X 
X 
X 
X 
X 
Drug/alcohol screen h 
X 
X 
Randomization 
X 
Dosing of study drug 
X 
Reactogenicity/injection site 
inspection i 
X 
X 
X 
PK sample collection j 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Samples for metabolite 
identification and CD388 DAR 
distribution k 
X 
X 
X 
X 
X 
X 
Samples for CD388 glycoforms l 
predose 
X 
X 
X 
X 
X 
X 
X 


 
 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 40 of 125 
Day 
(Window) 
Screening 
Clinical Research Unit (CRU) Inpatient Stay 
Outpatient CRU Visits 
-28 to -2 
-1 
1 
2 
3–6 
7 
9 
11 
14 
21 
30 
45 
(±3) 
84 
(±5) 
126 
(±7) 
168 
(±14) 
206 a 
(±10) 
Pharmacogenomics blood sample m 
predose 
Exploratory biomarker samples 
predose 
X e 
Anti-drug antibodies 
predose 
X 
X 
X 
X 
X 
X 
X 
Nasopharyngeal swab/nasal wash 
collection n 
predose 
X 
X 
X 
X 
X 
X 
X 
X 
Assess and record AEs o 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications/ 
procedures review p 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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; OV = outpatient visit; PK = pharmacokinetic; RR = respiration rate; SARS-CoV-2 = severe 
acute respiratory syndrome coronavirus 2. 
Schedule of Events: Single Dose, Cohort 4B 
a. For subjects who discontinue study early, the Day 206 procedures should be performed. 
b. On Day 1, the targeted physical examination should be performed predose. Vital signs collection will occur predose, 6 hours postdose, and as 
clinically indicated. 
c. 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 and semi-recumbent when ECG is being conducted. 
d. Continuous 12-lead digital ECG recording will be performed using a 12-lead Holter ECG monitor. Pharmacodynamic ECG tracings, including all 12-
leads and of 10 seconds duration, will be extracted in triplicate for 5-minute observation period starting from 1 hour before dosing, then at 72, 76, 80, 84, 
96, 102, 106, 110, 118, and 120 hours after administration of study drug, and stored in a digital format. The Holter monitor will be removed on Day 6. 
The Holter monitor may be removed once on Day 5 for up to 15 minutes for shower/bathing, at least 1 hour away from the next ECG timepoint. 
e. Laboratory evaluations need to be performed once during the Day 3–6 interval. 
f. 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). 
g. A sensitive serum pregnancy test (β‑human chorionic gonadotropin) is required at screening and OV4 for females of childbearing potential. 
FSH (if applicable to confirm postmenopausal status) is only required once. Urine pregnancy test may be performed at all other time points. 
h. Drug and alcohol screen is to be performed during the outpatient visits if vital signs are abnormal (see in protocol Appendix 2). 


 
 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 41 of 125 
Schedule of Events: Single Dose, Cohort 4B (continued) 
i. 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), with any abnormal findings reported as AEs. Reactions will be rated according to the scale 
provided in protocol Table 7. 
j. Blood samples for PK analysis will be collected predose (-24 hour window); post-dose at 12 and 24 hours (±30 minute window); 48 hours (±1 hour window); 
72, 84, 96, 108, 120 hours (each ±2 hour window); and Days 7, 9, 11, 14, 21, 30 (each ±2 hour window). Postdose samples collected at outpatient CRU 
visits at Days 45, 84, 126, 168, and 206 have the same windows (i.e., in ±days) as the visits. 
k. Blood samples for metabolite identification (e.g., free zanamivir, zanamivir dimers) will be collected on Day 1 at 2 hours postdose, on Day 2 at 24 hours 
postdose, on Day 30, Day 84, and on Day 126. Urine samples for metabolite identification will be collected from 0–48 hours, from 48–96 hours, and 
from 96–144 hours postdose, and over a 24 hour period on Days 10, 14, and 21, and over a 24-hour period that starts on Day 29 and ends prior to CRU 
check-out on Day 30. 
l. Serum samples for CD388 glycoforms will be collected predose on Day 1 and once in the morning on Days 2, 7, 14, 21, and 30, and at the Day 45 
and Day 126 visits. 
m. 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. 
n. Nasopharyngeal swab samples will be collected predose on Day 1, and on Days 2, 5, 7, 9, 11, 14, 21, and 30. Nasal wash collection will occur on Day 7. 
o. 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 205 days after the dose of study drug (Day 206 ±10 days) (this final AE assessment will be conducted via a follow-up phone 
call to the subject). 
p. Concomitant procedures used to treat an AE will be recorded from the time of CD388 Injection/placebo administration until the final study visit. 
 
 


 
 
 
Protocol No. CD388.IM.SQ.1.01|Altasciences Project No. CID-P1-144| Version Final Amendment 3.0 | 2023-12-20 
Page 42 of 125 
APPENDIX D LABORATORY NORMAL REFERENCE RANGES 
HEMATOLOGY 
Laboratory Parameter (Unit) 
Normal Reference Range 
Absolute basophils, cells/uL 
Male gender, Age to 133Y: 0-200 
Female gender, Age to 133Y: 0-200 
Absolute eosinophils, cells/uL 
Male gender, Age to 133Y: 15-500 
Female gender, Age to 133Y: 15-500 
Absolute lymphocytes, cells/uL 
Male gender, Age to 18Y: 1200-5200 
Male gender, Age to 133Y: 850-3900 
Female gender, Age to 18Y: 1200-5200 
Female gender, Age to 133Y: 850-3900 
Absolute monocytes, cells/uL 
Male gender, Age to 18Y: 200-900 
Male gender, Age to 133Y: 200-950 
Female gender, Age to 18Y: 200-900 
Female gender, Age to 133Y: 200-950 
Absolute neutrophils, cells/uL 
Male gender, Age to 18Y: 1800-8000 
Male gender, Age to 133Y: 1500-7800 
Female gender, Age to 18Y: 1800-8000 
Female gender, Age to 133Y: 1500-7800 
Erythrocytes, (million/uL) 
Male gender, Age to 18Y: 4.10-5.70 
Male gender, Age to 133Y: 4.20-5.80 
Female gender, Age to 18Y: 3.80-5.10 
Female gender, Age to 133Y: 3.80-5.10 
Hematocrit, % 
Male gender, Age to 18Y: 36.0-49.0 
Male gender, Age to 133Y: 38.5-50.0 
Female gender, Age to 18Y: 34.0-46.0 
Female gender, Age to 133Y: 35.0-45.0 


 
 
 
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Laboratory Parameter (Unit) 
Normal Reference Range 
Hemoglobin, g/dL 
Male gender, Age to 18Y: 12.0-16.9 
Male gender, Age to 133Y: 13.2-17.1 
Female gender, Age to 18Y: 11.5-15.3 
Female gender, Age to 133Y: 11.7-15.5 
Mean Corpuscular Hemoglobin (pg) 
Male gender, Age to 18Y: 25.0-35.0 
Male gender, Age to 133Y: 27.0-33.0 
Female gender, Age to 18Y: 25.0-35.0 
Female gender, Age to 133Y: 27.0-33.0 
Mean Corpuscular Volume (fL) 
Male gender, Age to 18Y: 78.0-98.0 
 Male gender, Age to 133Y: 80.0-100.0 
 Female gender, Age to 18Y: 78.0-98.0 
 Female gender, Age to 133Y: 80.0-100.0 
Leukocytes, (thousands/uL) 
Male gender, Age to 18Y: 4.10-5.70 
Male gender, Age to 133Y: 4.20-5.80 
Female gender, Age to 18Y: 3.80-5.10 
Female gender, Age to 133Y: 3.80-5.10 
Platelet count, thousands/uL 
Male gender, Age to 133Y: 140-400 
Female gender, Age to 133Y: 140-400 
SERUM CHEMISTRY 
Laboratory Parameter ,Unit 
Normal Reference Range 
Alanine aminotransferase, U/L 
Male gender, Age to 133Y: 9-46 
Female gender, Age to 133Y: 6-29 
Albumin, g/dL 
Male gender, Age to 133Y: 3.6-5.1 
Female gender, Age to 133Y: 3.6-5.1 
Alkaline phosphatase, U/L 
Male gender, Age to 19Y: 46-169 
Male gender, Age to 49Y: 36-130 
Male gender, Age to 133Y: 35-144 


 
 
 
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Laboratory Parameter ,Unit 
Normal Reference Range 
Female gender, Age to 19Y: 36-128 
Female gender, Age to 49Y: 31-125 
Female gender, Age to 133Y: 37-153 
Asparate Aminotransferase, U/L 
Male gender, Age to 133Y: 7-25 
Female gender, Age to 133Y: 7-25 
Amylase, U/L 
Male gender, Age to 133Y: 21-101 
Female gender, Age to 133Y: 21-101 
Bilirubin total, mg/dL 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Blood urea nitrogen, mg/dL 
Male gender, Age to 19Y: 7-20 
Male gender, Age to 133Y: 7-25 
Female gender, Age to 19Y: 7-20 
Female gender, Age to 133Y: 7-25 
Calcium, mg/dL 
Male gender, Age to 19Y: 8.9-10.4 
Male gender, Age to 133Y: 8.6-10.3 
Female gender, Age to 19Y: 8.9-10.4 
Female gender, Age to 49Y: 8.6-10.2 
Female gender, Age to 133Y: 8.6-10.4 
Carbon dioxide , mmol/L 
Male gender, Age to 133Y: 20-32 
Female gender, Age to 133Y: 20-32 
Chloride, mmol/L 
Male gender, Age to 133Y: 98-110 
Female gender, Age to 133Y: 98-110 


 
 
 
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Laboratory Parameter ,Unit 
Normal Reference Range 
Creatinine, mg/dL 
Male gender, Age to 19Y: 0.60-1.26 
Male gender, Age to 49Y: 0.60-1.35 
Male gender, Age to 59Y: 0.70-1.33 
Male gender, Age to 69Y: 0.70-1.25 
Male gender, Age to 79Y: 0.70-1.18 
Male gender, Age to 133Y: 0.70-1.11 
Female gender, Age to 19Y: 0.50-1.00 
Female gender, Age to 49Y: 0.50-1.10 
Female gender, Age to 59Y: 0.50-1.05 
Female gender, Age to 69Y: 0.50-0.99 
Female gender, Age to 79Y: 0.60-0.93 
Female gender, Age to 133Y: 0.60-0.88 
Creatinine Clearance, Estimated, mL/min 
Male gender, Age to 133Y: >/=90 mL/Min 
Female gender, Age to 133Y: >/=90 mL/Min 
Glucose, nonfasting, mg/dL 
Male gender, Age to 133Y: 65-139 
Female gender, Age to 133Y: 65-139 
Lactate dehydrogenase, U/L 
Male gender, Age to 49Y: 100-220 
Male gender, Age to 133Y: 120-250 
Female gender, Age to 49Y: 100-200 
Female gender, Age to 133Y: 120-250 
Lipase, U/L 
Male gender, to 133Y: 7-60  
Female gender, to 133Y: 7-60  
Phosphorus, mg/dL 
Male gender, Age 18Y: 3.0-5.1 
Male gender, Age 20Y: 2.7-5.0 
Male gender, Age to 64Y: 2.5-4.5 
Male gender, Age to 133Y: 2.1-4.3 
Female gender, Age: 18Y: 3.0-5.1 
Female gender, Age: 20Y: 2.7-5.0 
Female gender, Age to 64Y: 2.5-4.5 
Female gender, Age to 133Y: 2.1-4.3 


 
 
 
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Laboratory Parameter ,Unit 
Normal Reference Range 
Potassium, mmol/L 
Male gender, Age to 19Y: 3.8-5.1 
Male gender, Age to 133Y: 3.5-5.3 
Female gender, Age to 19Y: 3.8-5.1 
Female gender, Age to 133Y: 3.5-5.3 
Protein total, g/dL 
Male gender, Age to 19Y: 6.3-8.2 
Male gender, Age to 133Y: 6.1-8.1 
Female gender, Age to 19Y: 6.3-8.2 
Female gender, Age to 133Y: 6.1-8.1 
Sodium, mmol/L 
Male gender, Age to 133Y: 135-146 
Female gender, Age to 133Y: 135-146 
Serum beta human chorionic gonadotropin 
(β-hCG), TOTAL, QL 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: Non-Pregnant:  Negative; Pregnant:  Positive 
Follicle-stimulating hormone (FSH) 
Female gender, Age to 133Y: 
Follicular Phase:  2.5-10.2 
Mid-cycle Phase:  3.1-17.7 
Luteal Phase:  1.5-9.1 
Postmenopausal:  23.0-116.3 
LIPIDS 
Laboratory Parameter , Unit 
Normal Reference Range 
Triglycerides, mg/dl 
Male gender, Age to 19Y: <90 
Male gender, Age to 133Y: <150 
Female gender, Age to 19Y: <90 
Female gender, Age to 133Y: <150 
Low Density Lipoprotein (LDL), mg/dl 
Male gender, Age to 19Y: <110 
Male gender, Age to 133Y: <100 
Female gender, Age to 19Y: <110 
Female gender, Age to 133Y: <100 


 
 
 
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Cholesterol, Total, mg/dl 
Male gender, Age to 19Y: >45 
Male gender, Age to 133Y: > OR = 40 
Female gender, Age to 19Y: >45 
Female gender, Age to 133Y: > OR = 50 
COAGULATION 
Laboratory Parameter , Unit 
Normal Reference Range 
Activated partial thromboplastin time, seconds 
Male gender, Age to 133Y: 23-32 
Female gender, Age to 133Y: 23-32 
Prothrombin, International normalized ratio (INR), Ratio  
Male gender, Age to 133Y: 0.9-1.1 
Female gender, Age to 133Y: 0.9-1.1 
Prothrombin Time, seconds 
Male gender, Age to 133Y: 9.0-11.5 
Female gender, Age to 133Y: 9.0-11.5 
COMPLEMENT ACTIVATION 
Laboratory Parameter , Unit 
Normal Reference Range 
Complement Component C3C (C3, C4, CH50), mg/dl 
Male gender, Age to 80Y: 82-193 
Male gender, Age > or = 81Y: Not Established 
Female gender, Age to 80Y: 82-193 
Female gender, Age > or = 81Y:  Not Established 


 
 
 
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URINALYSIS 
Laboratory Parameter 
Normal Reference Range 
Appearance 
Male gender, Age to 133Y: CLEAR  
Female gender, Age to 133Y: CLEAR 
Bilirubin  
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Color 
Male gender, Age to 133Y: YELLOW  
Female gender, Age to 133Y: YELLOW 
Erythrocyte (/HPF) 
Male gender, Age to 133Y: < or = 2 
Female gender, Age to 133Y: < or = 2 
Glucose 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Ketones 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Leukocyte Esterase 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Nitrite 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Occult Blood 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
pH 
Male gender, Age to 133Y: 5.0-8.0  
Female gender, Age to 133Y: 5.0-8.0 
Protein 
Male gender, Age to 133Y: Negative 
Female gender, Age to 133Y: Negative 
Specific Gravity 
Male gender, Age to 133Y: 1.001-1.035  
Female gender, Age to 133Y: 1.001-1.035 


 
 
 
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SEROLOGY 
Laboratory Parameter , Unit 
Normal Reference Range 
Hepatitis B surface antigen (HBsAg) 
Male gender, Age to 133Y: NON-REACTIVE  
Female gender, Age to 133Y: NON-REACTIVE 
Hepatitis C antibody 
Male gender, Age to 133Y: NON-REACTIVE  
Female gender, Age to 133Y: NON-REACTIVE 
Human immunodeficiency virus (HIV) antibody 
Male gender, Age to 133Y: NON-REACTIVE  
Female gender, Age to 133Y: NON-REACTIVE 
 
OTHER 
Laboratory Parameter , Unit 
Normal Reference Range 
Opioids 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Benzodiazepines 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Barbiturates 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Cocaine metabolites 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Cannabinoids 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Methamphetamines 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Phencyclidine 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 


 
 
 
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Amphetamine 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Cotinine, MCG/m: 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
Alcohol 
Male gender, Age to 133Y: NEGATIVE 
Female gender, Age to 133Y: NEGATIVE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Page 51 of 125 
 
 
 
TABLE, FIGURE, AND LISTING 
SHELLS 
Cidara Therapeutics, Inc. 
 
PROTOCOL No.: CD388.IM.SQ.1.01 
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single Dose, Dose-Escalation 
Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or 
Subcutaneous Administration in Healthy Subjects 
Protocol Version (Date): 
Amendment  2.0 (07-Feb-2023) 
Altasciences Project No. CID-P1-144 
 
Prepared by: 
Altasciences Inc. 
575 Armand-Frappier Boulevard 
Laval, Quebec 
Canada, H7V 4B3 
Version: Final Amendment 3.0 
Date: 2023-12-20 
 
 


 
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Page 52 of 125 
Version Control 
 
Version 
Date 
Author 
Description of Changes 
1.0 
2022-06-08 
Riddhi Thakkar/ 
Blake Scadden 
Not applicable 
1.1 
2023-04-05 
Riddhi Thakkar/ 
Blake Scadden 
A SAP is being updated due to the 
protocol amendment 2.0 (07-Feb-2023) 
which added a new cohort 4B for SQ route.  
All impacted sections are updated. 
1.2 
2023-07-12 
Logan Kowallis 
Added relative bioavailability model 
table – Table 14.6.2.1. 
2.0 
2023-07-31 
Anita Shanker 
Changes described in 1.1 & 1.2 
3.0 
2023-12-20 
Haleh Aghamolaey 
Shells are being amended to align the 
changes that were made to SAP Amendment 
3.0. This version also addresses layout 
changes to match with protocol. Shells 
layouts for reactogenicity are updated 
to have a clear presentation of the 
content. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Page 53 of 125 
12 
MOCK SHELLS ..................................................................................................................................................................... 55 
12.1 
Table Mock Shells ........................................................................................................................ 55 
Template T1.1: Subject Disposition (All Subjects) .........................56 
Template T1.2: Demographics and Baseline Characteristics (Safety Population)
 
58 
Template T1.3: Protocol Deviation (Safety Population) .....................60 
Template T2.1: Pharmacokinetic Data of CD388– Plasma (Pharmacokinetic 
Population), ..............................................................61 
Template T2.2: Pharmacokinetic Parameters Summaries of CD388– Plasma 
(Pharmacokinetic Population) ..............................................62 
Template T2.3: PK Parameters Assessment of CD388 for <Cohort> SQ relative to 
IM – (Pharmacokinetic Population) .........................................63 
Template T2.4: Dose Proportionality Analysis – (Pharmacokinetic Population)
 
64 
Template T3.1: Treatment-Emergent Adverse Events (TEAEs) - Overall Summary 
(Safety Population) .......................................................67 
Template T3.2: Treatment-Emergent Adverse Events (TEAEs) by System Organ 
Class and Preferred Term (Safety Population) ..............................69 
Template T3.3: Drug-Related Treatment-Emergent Adverse Events (TEAEs) by 
System Organ Class and Preferred Term (Safety Population) .................70 
Template T3.4: Treatment-Emergent Adverse Events (TEAEs) by System Organ 
Class, Preferred Term, and Maximum Severity (Safety Population) ...........72 
Template T3.5: Serious Treatment-Emergent Adverse Events (TEAEs) by System 
Organ Class and Preferred Term (Safety Population) ........................74 
Template T3.6: Influenza-like Treatment-Emergent Adverse Events (TEAEs) by 
System Organ Class and Preferred Term (Safety Population) .................76 
Template T4.1: Summary of <Laboratory Panel> (Safety Population) ..........78 
Template T4.2: Summary of Potentially Clinically Significant (PCS) Values 
<Laboratory Panel> (Safety Population) ....................................80 
Teplate T5.1: Summary of Vital Signs (Safety Population) ..................82 
Template T5.2: Summary of Potentially Clinically Significant (PCS) Values 
Vital Signs (Safety Population) ...........................................84 
Template T5.3: ECG: Observed Values and Changes from Baseline (Safety 
Population) ...............................................................86 
Template T5.4: ECG: Maximum QTcF Categorical Analysis (Safety Population) .88 
Template T5.4: Reactogenicity/Injection Site Inspection (Safety Population)
 
90 
12.2 
Figure Mock Shells ...................................................................................................................... 91 
Template F1: Mean (+SD) Concentration-Time Profile – Plasma (PK Population)
 
92 
Template F2: Box-and-Whiskers Plot of Plasma CD388 <PKPARAM> – Plasma (PK 
Population) ...............................................................94 
Template F3: Individual Plasma CD388 Concentration-Time Profiles – (PK 
Population) ...............................................................96 
12.3 
Listing Mock Shells ...................................................................................................................... 98 
Template L1: Randomization ................................................99 
Template L2: Subject Disposition (Safety Population) .....................100 
Template L3.1: Protocol Deviations (Safety Population) ...................101 
Template L3.2: Pharmacokinetic Blood Sample Deviations (Safety Population)
 
102 
Template L4.1: Inclusion/Exclusion Criteria Violations (Safety Population)
 
103 


 
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Template L4.2: Analysis Population .......................................104 
Template L5.1: Demographics and Informed Consent (Safety Population) .....105 
Template L5.2: Medical History (Safety Population) .......................106 
Template L5.3: Prior and Concomitant Medications (Safety Population) .....107 
Template L6.1: Investigational Product Administration (Safety Population) 108 
Template L7.1: Individual Plasma CD388 Pharmacokinetic Data (PK Population)
 
109 
Template L7.2: Individual Urine Concentration Data (PK Population) .......110 
Template L7.3: Individual Plasma CD388 Pharmacokinetic Parameters (PK 
Population) ..............................................................111 
Template L7.4: Actual Pharmacokinetic Plasma Sampling Times (PK Population)
 
112 
Template L7.5: Anti-Drug Antibodies (Safety Population) ..................113 
Template L8: Adverse Events (Safety Population) ..........................114 
Template L9.1: <Laboratory Panel> (Safety Population) ....................115 
Template L9.2: Serology (Safety Population) ..............................116 
Template L9.3: Urine Drugs of Abuse Screen (Safety Population) ...........117 
Template L9.4: Pregnancy Test (Safety Population) ........................119 
Template L9.5: FSH Test (Safety Population) ..............................119 
Template L10.1: Vital Signs (Safety Population) ..........................121 
Template L10.2: 12-Lead Electrocardiogram (ECG) (Safety Population) ......122 
Template L10.4: Physical Examination (Safety Population) .................123 
Template L10.5: Reactogenicity/Injection Site Inspection (Safety Population)
 
124 


 
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TABLE 14.2.1 MOCK SHELLS 
TABLE MOCK SHELLS 
The templates indicate the content that will be presented in the summary tables. The appearance, 
e.g., the layout of the table, fonts, footnotes, or other typographic detail, may be different in the 
final versions of the tables. 
 
 


 
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Page 56 of 125 
 
 
Table 14.2.3 
Template T1.1: Subject Disposition (All Subjects) 
Table 14.1.1.1 
Subject Disposition 
(All Subjects) 
 
 
 
IM Route 
 
SQ Route 
 
 
CD388 50 
mg 
CD388 
150 mg 
CD388 
450 mg 
Pooled  
Placebo 
 CD388 50 
mg 
CD388 
150 mg 
CD388 
450 mg 
CD388 
900 mg 
Pooled 
Placebo 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subjects Randomized 
[N] 
 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
Subjects Completed 
the Study [n(%)] 
Yes 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
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) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
If No, Primary Reason 
for Study Withdrawal 
[n(%)] 
Reason 1 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
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) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
Reason 3 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x)  
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
… 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x)  
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
  
 
 
 
 
 
 
 
 
 
 
If No, Primary Reason 
for Treatment 
Withdrawal [n(%)] 
Reason 1 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
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) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
Reason 3 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x)  
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
… 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x)  
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Number of Subjects 
Included in Each 
Analysis Population 
[n(%)] 
Enrolled 
Population 
xx  
xx  
xx  
xx  
 
xx  
xx  
xx  
xx  
xx  
 
Safety 
Population 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 


 
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PK 
Population 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
Date: VERSION - YYYY-MM-DD 
 
Data Source: XXXX 
 
 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note: The percentages will be calculated using the number of subjects in each cohort and study drug group as the denominator. 
<Programming Note> It can be presented separately (i.e. IM one page and SQ another). 
 


 
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Table 14.2.4 
Template T1.2: Demographics and Baseline Characteristics (Safety Population) 
Table 14.1.2.1 
Demographics and Baseline Characteristics  
(Safety Population) 
 
 
IM Route 
 
SQ Route 
 
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX) 
 CD388 50 
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg  
(N = XX) 
CD388 900 
mg  
(N = XX) 
Pooled 
Placebo  
(N = XX) 
  
  
 
 
 
 
 
 
 
 
 
 
Age (years) 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
Minimum, 
Maximum 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Sex [n(%)] 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Male 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  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) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Race [n(%)] 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Race1 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  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) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
… 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Ethnicity 
[n(%)] 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Hispanic/Latino xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
Not 
Hispanic/Latino 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Weight (kg)  
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
Minimum, 
Maximum 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Height (cm) 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
Minimum, 
Maximum 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Body Mass 
Index (kg/m2) 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
Median 
xx.x 
xx.x 
xx.x 
xx.x 
 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 


 
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Minimum, 
Maximum 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note: Percentages are based on the number of subjects in the Safety population as the denominator. 
Programming Note: Table 14.1.2.2: “Demographics and Baseline Characteristics – PK Population” will follow the same layout. 
 
 
 


 
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Table 14.2.5 
Template T1.3: Protocol Deviation (Safety Population) 
Table 14.1.1.3 
Protocol Deviation 
(Safety Population) 
 
 
IM Route 
 
SQ Route 
 
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX) 
 CD388 50 
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg 
(N = XX)  
CD388 900 
mg 
 (N = XX) 
Pooled Placebo  
(N = XX) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deviation 
Category 
 
Major 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
xx (xx.x) 
 
… 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note: Percentages are based on the number of subjects in the safety population as the denominator. 


 
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Table 14.2.6 
Template T2.1: Pharmacokinetic Data of CD388– Plasma (Pharmacokinetic Population), 
Table 14.2.1.1.1.x 
Descriptive Statistics of Plasma CD388 Concentration Data Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>) 
(PK Population) 
 
  
Time 
(h)  
0 
2 
4 
12 
24 
48 
72 
…. 
696 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
  
Concentration 
(Units) 
  
  
  
N 
  
  
  
  
  
  
  
  
  
  
  
  
Mean 
  
  
  
  
  
  
  
  
  
  
  
  
SD 
  
  
  
  
  
  
  
  
  
  
  
  
Min 
  
  
  
  
  
  
  
  
  
  
  
  
Median 
  
  
  
  
  
  
  
  
  
  
  
  
Max 
  
  
  
  
  
  
  
  
  
  
  
  
CV% 
  
  
  
  
  
  
  
  
  
Lower Limit of Quantitation is xx.x (Units) 
NC: Not Calculated, NS: No Sample 
 
x = 1 through 8 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B and PK Completer Population (Cohorts 2A, 2B, 3A and 3B only) 
<DOSE> = 50 mg, 150 mg, 450 mg, and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note:  
 
Table 14.2.1.1.2.x: “Descriptive Statistics of Plasma CD388 Concentration Data Following a Repeated Single <ADMIN> of <DOSE> CD388 
to Healthy Subjects (<COHORT>) >” will follow the same layout. 
 
Table 14.2.2.1.1.x: “Descriptive Statistics of Nasopharyngeal CD388 Concentration Data Following a Single <ADMIN> of <DOSE> CD388 
to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
Table 14.2.2.1.2.x: “Descriptive Statistics of Nasopharyngeal CD388 Concentration Data Following a Repeated Single <ADMIN> of 
<DOSE> CD388 to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
 
 


 
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Table 14.2.7 
Template T2.2: Pharmacokinetic Parameters Summaries of CD388– Plasma (Pharmacokinetic Population) 
Table 14.2.1.2.1.x 
Descriptive Statistics of Plasma CD388 Pharmacokinetic Parameter Estimates Following a Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>) 
(PK Population) 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
  
Cmax  
(Unit) 
Tmax 
(Unit) 
AUC0-t 
(Unit) 
… 
Vz/F  
(Unit) 
  
  
  
N 
  
  
  
  
  
  
  
  
Mean 
  
  
  
  
  
  
  
  
SD 
  
  
  
  
  
  
  
  
Min 
  
  
  
  
  
  
  
  
Median 
  
  
  
  
  
  
  
  
Max 
  
  
  
  
  
  
  
  
CV% 
  
  
  
  
  
  
  
  
GeoMean 
  
  
  
  
  
  
  
  
GeoMean CV% 
  
  
  
  
  
NC: Not Calculated 
 
x = 1 through 8 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B and PK Completer Population (Cohorts 2A, 2B, 3A and 3B only) 
<DOSE> = 50 mg, 150 mg, 450 mg and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note:  
 
Table 14.2.1.2.2.x: “Descriptive Statistics of Plasma CD388 Pharmacokinetic Parameter Estimates Following a Repeated Single <ADMIN> 
of <DOSE> CD388 to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
Table 14.2.2.2.1.x:  “Descriptive Statistics of Nasopharyngeal CD388 Pharmacokinetic Parameter Estimates Following a Single <ADMIN> 
of <DOSE> CD388 to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
Table 14.2.2.2.2.x: “Descriptive Statistics of Nasopharyngeal CD388 Pharmacokinetic Parameter Estimates Following a Repeated Single 
<ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
 
 


 
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Table 14.2.8 
Template T2.3: PK Parameters Assessment of CD388 for <Cohort> SQ relative to IM – (Pharmacokinetic 
Population) 
Table 14.2.3.1 
Statistical Analysis of Plasma CD388 Pharmacokinetic Parameters Between IM and SQ Administration 
 (PK Population) 
 
   
 
Geometric LSmeans [1] 
 
90% Confidence Interval (%) 
Dose 
Parameter 
(unit) 
 
n 
IM Route 
SQ route 
SQ/IM 
Ratio (%) 
Lower Bound 
Upper Bound 
 
 
 
  
 
 
 
 
xx mg 
 
 
 
 
 
 
 
 
Cmax 
(unit) 
xxx 
xxxxxx 
xxxxxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
AUC0-t 
(unit) 
xxx 
xxxxxx 
xxxxxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
AUC0-∞ 
(Unit) 
xxx 
xxxxxx 
xxxxxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
Date: VERSION – YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
 
 
IM = Intramuscular(Reference); SQ = Subcutaneous(Test) 
 
[1] Geometric Least Square (LS)means are based on the exponential of LSmeans of ln-transformed values 
Note(s):   
An analysis of variance (ANOVA) was performed on the ln-transformed parameters with the following fixed 
factors:  Injection route.  
The ratio and 90% confidence interval (CI) were obtained by exponentiating the resulting difference between each 
comparison of interest (IM to SQ) least-squares means and its corresponding 90% CI. 
 
 
 
 
 


 
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Table 14.2.10 
Template T2.4: Dose Proportionality Analysis – (Pharmacokinetic Population)  
Table 14.2.4.1 
Dose Proportionality Analysis of Plasma CD388 Pharmacokinetic Parameters  
(PK Population) 
 
   
n 
Estimate of 
Intercept (α) 
Estimate of 
Slope (β) 
90% Confidence Interval of Slope 
Route 
Parameter 
(Unit) 
Lower Bound 
Upper Bound 
IM 
 
 
 
 
 
 
 
Cmax (Unit) 
xxx  
xxx  
xxx  
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
AUC0-t(Unit) 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
AUC0-∞ (Unit) 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
SQ 
 
 
 
 
 
 
 
Cmax (Unit) 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
AUC0-t(Unit) 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
AUC0-∞ (Unit) 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
Date: VERSION – YYYY-MM-DD 
Data Source: 
XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note: Proportionality analysis was performed using a power model: ln(PK parameter) = α + β × ln(dose) + error, with 
β as slope.  
 
 
 
 
 
 
 


 
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Table 14.2.5.1 
Summary of Positive Anti-drug Antibodies Titer 
(Safety Population) 
 
IM Route 
 
SQ Route 
 
CD388 50  
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
CD388 50  
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg  
(N = XX) 
CD388 900 
mg  
(N = XX) 
Pooled  
Placebo  
(N = XX) 
 
n(%) 
n(%) 
n(%) 
n(%) 
 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
 
 
 
 
 
 
 
 
 
 
 
Positive ADA xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  
xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) 
xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous.  
Notes: Percentages are based on the number of subjects in the Safety population (N). 
 
 


 
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Table 14.2.6.1 
Relative Bioavailability Analysis of Plasma CD388 Pharmacokinetic Parameters  
(PK Population) 
 
   
n 
LSMeans 
Dose 1 
LSMeans 
Dose 2 
 
90% Confidence Interval of Difference 
Route Parameter (Unit) 
Dose 1/Dose 2 
Difference 
Lower Bound 
Upper Bound 
IM 
 
 
 
 
 
 
 
 
Cmax (Unit) 
xxx 
xxx  
xxx  
xxx  
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
AUC0-t(Unit) 
xxx 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
AUC0-∞ (Unit) 
xxx 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
SQ 
 
 
 
 
 
 
 
 
Cmax (Unit) 
xxx 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
AUC0-t(Unit) 
xxx 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
AUC0-∞ (Unit) 
xxx 
xxx 
xxx 
xxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
 
Date: VERSION – YYYY-MM-DD 
Data Source: XXXX  
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note:  ANOVA model includes dose as fixed factor. 
 
 


 
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Table 14.2.13 
Template T3.1: Treatment-Emergent Adverse Events (TEAEs) - Overall Summary (Safety Population) 
Table 14.3.1.1 
Treatment-Emergent Adverse Events (TEAEs) - First Dose - Overall Summary  
(Safety Population) 
 
IM Route 
 
SQ Route 
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX) 
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 
450 mg  
(N = XX) 
CD388 900 
mg  
(N = XX) 
Pooled 
Placebo  
(N = XX) 
 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
Subjects With at Least One 
TEAE [1][2] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Subjects With At Least One 
Drug-Related TEAE [2] [3] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Maximum Severity [2] 
 
 
 
 
 
 
 
 
 
 
Mild 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
Moderate 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
Severe 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
Life-threatening 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
Death 
xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)  xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Subjects With at Least One 
TEAE SAE [2] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Subject with at Least One 
TEAE Drug-Related SAE [2] [3] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Death [2] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Leading to study withdrawal 
[2] 
xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) 
 
  
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous; TEAE = Treatment-Emergent Adverse Event. 
Notes:  
[1] A Treatment-Emergent Adverse Event (TEAE) is an adverse event which starts or worsens after treatment with study drug. 
[2] Percentages are based on the number of subjects in the Safety population (N). 
[3] Drug-related TEAEs are those TEAEs reported by the Investigator as having a “Reasonable Possibility” of being related to study 
treatment.  
 


 
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<Programming Note> 
 
Table 14.3.1.2: “Treatment-Emergent Adverse Events (TEAEs) - Second Dose - Overall Summary” i.e., Cohorts 2A, 2B, 3A, 3B, and 
pooled placebo of respective route will follow the same layout.  
 


 
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Table 14.2.14 
Template T3.2: Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term 
(Safety Population) 
Table 14.3.1.3 
Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term- First Dose  
(Safety Population) 
 
IM Route 
 
SQ Route 
MedDRA System Organ 
Class 
CD388 50 
mg 
(N = XX)  
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 CD388 50 
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg  
(N = XX) 
CD388 900 
mg  
(N = XX  
Pooled 
Placebo  
(N = XX) 
  Preferred Term 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
Subjects with at least 
one TEAE 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
… 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous. 
Notes:  
For each row category, a subject with two or more adverse events in that category is counted only once. 
Percentages are based on the number of subjects in the safety population (N). 
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 
 
<Programming Note> 
 
Table 14.3.1.4: “Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term- Second Dose” i.e., Cohorts 2A, 
2B, 3A, 3B and pooled placebo of respective route will follow the same layout.  
 


 
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Table 14.2.15 
Template T3.3: Drug-Related Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and 
Preferred Term (Safety Population) 
Table 14.3.1.5 
Drug-Related Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term- First Dose  
(Safety Population) 
 
IM Route 
 
SQ Route 
 
MedDRA System Organ 
Class 
CD388 50 
mg 
(N = XX)  
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 CD388 50 
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg  
(N = XX) 
CD388 900 
mg  
(N = XX) 
Pooled 
Placebo  
(N = XX) 
  Preferred Term 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
Subjects with at least 
one TEAE 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
… 
xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)   xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous. 
Notes:  
For each row category, a subject with two or more adverse events in that category is counted only once. 
Percentages are based on the number of subjects in the safety population (N). 
Drug-related TEAEs are those TEAEs reported by the Investigator as having a “Reasonable Possibility” of being related to study 
treatment.  
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 
<Programming Note> 


 
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Table 14.3.1.6: “Drug-Related Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term - Second Dose” 
i.e., Cohorts 2A, 2B, 3A, 3B, and pooled placebo of respective route will follow the same layout.  
Table 14.3.1.11: “Drug-Related Serious Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term – First 
Dose” will follow the same layout.  
Table 14.3.1.12: “Drug-Related Serious Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term – Second 
Dose” i.e., Cohorts 2A, 2B, 3A, 3B, and pooled placebo of respective route will follow the same layout. 
  
 


 
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Table 14.2.16 
Template T3.4: Treatment-Emergent Adverse Events (TEAEs) by System Organ Class, Preferred Term, and 
Maximum Severity (Safety Population) 
Table 14.3.1.7 
Treatment-Emergent Adverse Events (TEAEs) by System Organ Class, Preferred Term, and Maximum Severity – First Dose 
(Safety Population) 
 
 
 
IM Route 
SQ Route 
 
 
System Organ 
Class/ 
 
CD388 50 
mg 
(N = XX)  
CD388 
150 mg 
(N = 
XX) 
CD388 
450 mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)   
CD388 
50 mg 
(N = 
XX) 
CD388 
150  
mg  
(N = XX) 
CD388 
450 mg  
(N = XX) 
CD388 
900 mg  
(N = XX) 
Pooled 
Placebo  
(N = 
XX) 
  Preferred 
Term 
Maximum 
Severity 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
 
Subjects With 
at Least One 
TEAE 
Mild 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Moderate 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Severe 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Life-
threatening 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Death 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 1 
 
 
 
 
 
 
 
 
 
 
 
 
Mild 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Moderate 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Severe 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Life-
threatening 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Death 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
  PT 1 
Mild 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Moderate 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Severe 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
Life-
threatening 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 


 
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… 
Death 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
xx 
(xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 
IM = Intramuscular; SQ = Subcutaneous. 
Notes:  
For each PT, a subject with two or more adverse events in that category is counted only once at the maximum level. 
Percentages are based on the number of subjects in the safety population (N). 
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 
<Programming Note> 
 
Table 14.3.1.8: “Treatment-Emergent Adverse Events (TEAEs) by System Organ Class, Preferred Term, and Maximum Severity - Second 
Dose” i.e., Cohorts 2A, 2B, 3A, 3B, and pooled placebo of respective route will follow the same layout.   
 
 


 
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Table 14.2.17 
Template T3.5: Serious Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred 
Term (Safety Population) 
Table 14.3.1.9 
Serious Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term – First Dose  
(Safety Population) 
 
IM Route 
 
SQ Route 
MedDRA System Organ Class 
CD388 50  
mg 
(N = XX)  
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
CD388 50  
mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 450 
mg  
(N = XX) 
CD388 
900 mg  
(N = XX  
Pooled 
Placebo  
(N = XX) 
  Preferred Term 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
Subjects with at least one 
TEAE 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 1 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 1 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 2 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 3 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 2 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 1 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 2 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
PT 3 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
… 
xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  
xx 
(xx.x)  
xx (xx.x)  
 
 
 
 
 
 
 
 
 
IM = Intramuscular; SQ = Subcutaneous. 
Notes:  
For each row category, a subject with two or more adverse events in that category is counted only once. 
Percentages are based on the number of subjects in the safety population (N). 
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 
 
<Programming Note> 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 


 
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Table 14.3.1.10: “Serious Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term - Second Dose” i.e., 
Cohorts 2A, 2B, 3A, 3B, and pooled placebo of respective route will follow the same layout. 
 


 
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Table 14.2.18 
Template T3.6: Influenza-like Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and 
Preferred Term (Safety Population) 
Table 14.3.1.13 
Influenza-like Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term – First Dose 
(Safety Population) 
 
IM Route 
 
SQ Route 
MedDRA System Organ Class 
CD388 50 
 mg 
(N = XX)  
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
CD388 50 
 mg 
(N = XX) 
CD388 150 
mg  
(N = XX) 
CD388 
450 mg  
(N = XX) 
CD388 900 
mg  
(N = XX) 
Pooled 
Placebo  
(N = XX) 
  Preferred Term 
n (%) 
n (%) 
n (%) 
n (%) 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
Subjects with at least one 
TEAE 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 1 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
 
 
SOC 2 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 1 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 2 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
PT 3 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
… 
xx (xx.x)  xx (xx.x)  xx (xx.x) xx (xx.x)  xx (xx.x)  xx (xx.x) 
xx 
(xx.x)  
xx (xx.x)  xx (xx.x)  
 
 
 
 
 
 
 
 
 
IM = Intramuscular; SQ = Subcutaneous. 
Notes:  
For each row category, a subject with two or more adverse events in that category is counted only once. 
Percentages are based on the number of subjects in the safety population (N). 
Influenza-like TEAE are those events which were collected during Follow-up Period. 
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 
Date: VERSION - YYYY-MM-DD 
Data Source: XXXX 
Program Source:  XXXXX.sas 


 
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<Programming Note> 
 
Table 14.3.1.14: “Influenza-like Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term - Second Dose” 
i.e., Cohorts 2A, 2B, 3A, 3B and pooled placebo of respective route will follow the same layout.  
<Programming Note> 
 
Table 14.3.1.14: “Influenza-like Treatment-Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term - Second Dose” 
i.e., Cohorts 2A, 2B, 3A, 3B and pooled placebo of respective route won’t be populated if no data is available.  
 


 
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Table 14.2.19 
Template T4.1: Summary of <Laboratory Panel> (Safety Population) 
Table 14.3.2.x 
Summary of <Laboratory Panel>  
(Safety Population)  
<Parameter (Unit)> 
 
IM Route 
 
 
SQ Route 
Visit 
 
CD388 
50 mg 
(N = 
XX)  
 
CD388 150 
mg 
(N = XX) 
 
CD388 450 mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
 
CD388 50 mg 
(N = XX) 
 
CD388 150 mg 
(N = XX) 
 
CD388 450 mg 
(N = XX) 
CD388 900 
mg  
(N = XX) 
ETC. 
(N = XX) 
Obs
erv
ed 
Chan
ge 
from 
Base
line 
Obse
rved 
Change 
from 
Baselin
e 
Obser
ved 
Change 
from 
Baselin
e 
Observed 
Change 
from 
Baselin
e 
 
Observe
d 
Change 
from 
Baseli
ne 
Observe
d 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
Obse
rved 
Chang
e 
from 
Basel
ine 
Observed 
Change 
from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline 
[1] 
n 
xx 
 
xx 
 
xx 
 
xx 
 
 
xx 
 
xx 
 
xx 
 
xx 
 
xx 
 
 
Mean 
(SD) 
xx.
x 
(xx
.xx
) 
 
xx.x 
(xx.
xx) 
 
xx.x 
(xx.x
x) 
 
xx.x 
(xx.xx) 
 
 xx.x 
(xx.xx) 
 
xx.x 
(xx.xx) 
 
xx.x 
(xx.xx
) 
 
xx.x 
(xx.
xx) 
 
xx.x 
(xx.xx) 
 
 
Medi
an 
xx.
x 
 
xx.x 
 
xx.x 
 
xx.x 
 
 xx.x 
 
xx.x 
 
xx.x 
 
xx.x 
 
xx.x 
 
 
Mini
mum, 
Maxi
mum 
xx, 
xx 
 
xx, 
xx 
 
xx, 
xx 
 
xx, xx 
 
 xx, xx 
 
xx, xx 
 
xx, xx 
 
xx, 
xx 
 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day xx 
n 
xx xx 
xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
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.x
x) 
xx.x 
(xx.xx) 
xx.x 
(xx.xx) 
xx.x 
(xx.xx) 
 xx.x 
(xx.xx) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.
xx) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx) 
xx.x 
(xx.xx) 
 
Medi
an 
xx.
x 
xx.x xx.x xx.x 
xx.x 
xx.x 
xx.x 
xx.x  xx.x 
xx.x 
xx.x 
xx.x xx.x xx.x xx.x xx.x 
xx.x 
xx.x 
 
Mini
mum, 
Maxi
mum 
xx, 
xx 
xx, 
xx 
xx, 
xx 
xx, xx xx, 
xx 
xx, xx xx, xx xx, xx  xx, xx xx, xx xx, xx xx, 
xx 
xx, xx xx, 
xx 
xx, 
xx 
xx, 
xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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IM Route 
 
 
SQ Route 
Visit 
 
CD388 
50 mg 
(N = 
XX)  
 
CD388 150 
mg 
(N = XX) 
 
CD388 450 mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
 
CD388 50 mg 
(N = XX) 
 
CD388 150 mg 
(N = XX) 
 
CD388 450 mg 
(N = XX) 
CD388 900 
mg  
(N = XX) 
ETC. 
(N = XX) 
Obs
erv
ed 
Chan
ge 
from 
Base
line 
Obse
rved 
Change 
from 
Baselin
e 
Obser
ved 
Change 
from 
Baselin
e 
Observed 
Change 
from 
Baselin
e 
 
Observe
d 
Change 
from 
Baseli
ne 
Observe
d 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
Obse
rved 
Chang
e 
from 
Basel
ine 
Observed 
Change 
from 
Baseline 
Date: VERSION – YYYY-MM-
DD 
Data Source: xxx 
 
Program Source: xxx.sas 
 
     IM = Intramuscular; SQ = Subcutaneous; SD = Standard Deviation. 
    [1] Note: Baseline is the measurement of the last predose measurement was used. 
    <Laboratory Panel> = Hematology; Chemistry; Urinalysis; Coagulation; Lipid; 
    <Programming Note> 
    It can be presented separately (i.e., IM one page and SQ another). 
    ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 
 
 


 
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Table 14.2.20 
Template T4.2: Summary of Potentially Clinically Significant (PCS) Values <Laboratory Panel> (Safety 
Population) 
Table 14.3.2.6 
Number (Percentage) of Subjects with Potentially Clinically Significant (PCS) Values in Hematology at Any Post-baseline Visit 
Safety Population 
 
 
IM Route 
 
SQ Route 
 
Parameter  
  
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
Pooled 
Placebo 
(N = XX) 
 
CD388 50 
mg 
(N = XX) 
CD388 150 
mg 
(N = XX) 
CD388 450 
mg 
(N = XX) 
CD388 900  
mg 
(N = XX) 
ETC. 
(N = XX) 
 
Visit 
PCS 
Criteria n/m (%) n/m (%) n/m (%) n/m (%)  n/m (%) n/m (%) n/m (%) 
n/m (%) 
n/m(%) 
 
Albumin 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
Alanine 
aminotransfer
ase (F)  
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
Alanine 
aminotransfer
ase (M)  
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Pre-Dose 
Albumin 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
Alanine 
aminotransfer
ase (F)  
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx (xx.x) x/xx (xx.x) 
 
Alanine 
aminotransfer
ase (M)  
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
x/xx 
(xx.x) 
 
x/xx (xx.x) 


 
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Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
 
IM = Intramuscular; SQ = Subcutaneous 
Note: n is the number of subjects who met the PCS criteria. Denominator (m) is the number of subjects with non-PCS 
baseline and at least one post-baseline assessment when calculating the percentage. 
 
<Laboratory Panel> = Hematology; Chemistry; Urinalysis; Coagulation; Lipid; 
<Programming Note> 
ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 
It can be presented separately (i.e., IM one page and SQ another). 
 
 


 
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Table 14.2.21 
Teplate T5.1: Summary of Vital Signs (Safety Population) 
Table 14.3.3.1 
Summary of Vital Signs  
(Safety Population)  
<Parameter (Unit)> 
 
IM Route 
 
 
SQ Route 
Visit 
Timepoi
nt 
CD388 50  
mg 
(N = XX)  
CD388 150  
mg 
(N = XX) 
CD388 450 
 mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 CD388 50  
mg 
(N = XX) 
CD388 150  
mg  
(N = XX) 
CD388 450 
 mg  
(N = XX) 
CD388 900 
 mg  
(N = XX) 
 
ETC. 
(N = XX) 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
 
Observ
ed 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
Observ
ed 
Chang
e 
from 
Basel
ine 
 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Chang
e 
from 
Basel
ine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseli
ne 
Pre-
Dose 
n 
xx 
 
xx 
 
xx 
 
xx 
 
 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
) 
 
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 
 
xx.x 
 
xx.x 
 
 xx.x 
 
xx.x 
 
 
Minimu
m, 
Maximu
m 
xx, xx 
 
xx, xx 
 
xx, xx 
 
xx, xx 
 
 xx, xx 
 
xx, xx 
 
xx, xx 
 
 xx, xx 
 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day xx hrs 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx  xx 
xx 
xx 
xx 
 
Mean 
(SD) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
 xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
 xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
 
Median xx.x 
xx.x 
xx.x xx.x xx.x xx.x xx.x xx.x  xx.x xx.x xx.x xx.x xx.x xx.x  xx.x xx.x xx.x xx.x 
 
Minimu
m, 
Maximu
m 
xx, xx xx, xx xx, xx xx, 
xx 
xx, xx xx, 
xx 
xx, xx xx, 
xx 
 xx, xx xx, 
xx 
xx, xx xx, 
xx 
xx, xx xx, 
xx 
 xx, xx xx, 
xx 
xx, xx xx, 
xx 
… 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
 
Data Source: xxx 
 
 
 
 
Program Source: xxx.sas 
        IM = Intramuscular; SQ = Subcutaneous; SD = Standard Deviation. 
        Note: Baseline is the measurement of the last predose measurement was used. 
<Parameter (unit)> = Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Pulse Rate (beats/min), Temperature (C), 
Respiratory Rate (breaths/min) 
 
        <Programming Note> 
        ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 


 
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        It can be presented separately (i.e., IM one page and SQ another). 
 
 


 
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Table 14.2.22 
Template T5.2: Summary of Potentially Clinically Significant (PCS) Values Vital Signs (Safety Population) 
Table 14.3.3.2 
Number (Percentage) of Subjects with Potentially Clinically Significant (PCS) Values in Vital Signs at Post-baseline Visit 
Safety Population 
 
 
IM Route 
 
SQ Route 
Parameter / 
CD388 50 
mg 
(N = XX) 
CD388 150 
 mg 
(N = XX) 
CD388 450  
mg 
(N = XX) 
Pooled 
Placebo 
(N = XX) 
 
CD388 50 
 mg 
(N = XX) 
CD388 150  
mg 
(N = XX) 
CD388 450  
mg 
(N = XX) 
CD388 900  
mg 
(N = XX) 
ETC. 
(N = XX) 
Timepoint 
   PCS 
Criteria 
n/m (%) n/m (%) 
n/m (%) 
n/m (%) 
 n/m (%) 
n/m (%) 
n/m (%) 
n/m (%) 
n/m (%) 
Subjects 
with at 
least one 
PCS Value 
Systolic 
Blood 
Pressure 
 
 
 
 
 
 
 
 
 
 
 
<=90 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=140 mmHg x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
xxx.x) 
x (xx.x) 
x (xx.x) 
xxx.x) 
 
Diastolic 
Blood 
Pressure 
 
 
 
 
 
 
 
 
 
 
 
<=60 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=90 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
Pulse Rate 
 
 
 
 
 
 
 
 
 
 
 
<=50 
beats/min 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=100 
beats/min 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
… 
 
 
 
 
 
 
 
 
 
 
Pre-Dose Systolic 
Blood 
Pressure 
 
 
 
 
 
 
 
 
 
 
 
<=90 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=140 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
Diastolic 
Blood 
 
 
 
 
 
 
 
 
 
 


 
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Pressure 
 
<=60 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=90 mmHg 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
Pulse Rate 
 
 
 
 
 
 
 
 
 
 
 
<=50 
beats/min 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
 
>=100 
beats/min 
x (xx.x) x (xx.x) 
x (xx.x) 
x (xx.x) 
 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
x (xx.x) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
 
IM = Intramuscular; SQ = Subcutaneous. 
Note: n is the number of subjects who met the PCS criteria. Denominator (m) is the number of subjects with non-PCS 
baseline and at least one post-baseline assessment when calculating the percentage. 
 
<Programming Note> 
ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 
It can be presented separately (i.e., IM one page and SQ another). 
 
 
 


 
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Table 14.2.24 
Template T5.3: ECG: Observed Values and Changes from Baseline (Safety Population) 
Table 14.3.4.1 
ECG: Observed Values and Changes from Baseline 
(Safety Population)  
<Parameter (Unit)> 
 
IM Route 
 
 
SQ Route 
Visit 
Timepoi
nt 
CD388 50  
mg 
(N = XX)  
CD388 150 
 mg 
(N = XX) 
CD388 450  
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX)  
 
CD388 50  
mg 
(N = XX) 
CD388 150  
mg  
(N = XX) 
CD388 450 
 mg  
(N = XX) 
ETC. 
(N = XX) 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Chang
e 
from 
Basei
ne 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Change 
from 
Baseli
ne 
 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Change 
from 
Baseli
ne 
Observ
ed 
Change 
from 
Baseli
ne 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseli
ne 
n 
xx 
 
xx 
 
xx 
 
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
) 
 
xx.x 
(xx.xx
) 
 
xx.x 
(xx.xx
) 
 
xx.x 
(xx.xx
) 
 
 
Median 
xx.x 
 
xx.x 
 
xx.x 
 
xx.x 
 
 xx.x 
 
xx.x 
 
xx.x 
 
xx.x 
 
 
Minimu
m, 
Maximu
m 
xx, xx 
 
xx, xx 
 
xx, xx 
 
xx, xx 
 
 xx, xx 
 
xx, xx 
 
xx, xx 
 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day xx Pre-
Dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
 
Mean 
(SD) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.x
x) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
 xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
xx.x 
(xx.xx
) 
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 
xx.x 
xx.x 
xx.x  xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
Minimu
m, 
Maximu
m 
xx, xx xx, xx xx, xx xx, 
xx 
xx, xx xx, xx xx, xx xx, xx  xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx 
… 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
 
Data Source: xxx 
 
 
 
 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous; SD = Standard Deviation. 
Note: Baseline is the measurement of the last predose measurement was used. 
<Parameter (unit)> = ECG Mean Ventricular Rate (msec), PR Interval (msec), QRS Duration (msec), QT Interval (msec), QTcF Interval 
(msec) 


 
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<Programming Note> 
ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo . CD388 900 mg be added 
It can be presented separately (i.e., IM one page and SQ another). 
 
 


 
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Table 14.2.25 
Template T5.4: ECG: Maximum QTcF Categorical Analysis (Safety Population) 
Table 14.3.4.2  
ECG: Maximum QTcF Categorical Analysis  
(Safety Population) 
 
IM Route 
 
 
SQ Route 
Nominal 
Day 
Category 
CD388 
50 mg 
(N = 
XX)  
CD388 
150 mg 
(N = 
XX) 
CD388 450 
mg 
(N = XX) 
Pooled  
Placebo 
(N = XX) 
 CD388 50 
mg 
(N = XX) 
CD388 
150 mg 
(N = 
XX) 
CD388 
450 mg 
(N = 
XX) 
CD388 900 mg  
(N = XX) 
ETC. 
(N = XX) 
 
 
 
 
 
 
 
 
 
 
 
Day xx Absolute 
Values 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
> 450 msec and 
≤ 480 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 450 msec and 
≤ 500 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 500 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Increases 
from 
Baseline 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
> 30 msec and 
≤ 60 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 60 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
Day xx Absolute 
Values 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
 
> 450 msec and 
≤ 480 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 450 msec and 
≤ 500 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 500 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
Increases 
from 
Baseline 
n 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
xx 
… 
> 30 msec and 
≤ 60 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
> 60 msec 
xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
 xx (xx.x) xx 
(xx.x) 
xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 


 
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IM = Intramuscular; SQ = Subcutaneous; SD = Standard Deviation. 
Note: Baseline is the measurement of the last predose measurement was used. 
 
<Programming Note> 
ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 
It can be presented separately (i.e., IM one page and SQ another). 
 
 


 
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Table 14.2.26 
Template T5.4: Reactogenicity/Injection Site Inspection (Safety Population) 
Table 14.3.5.1 
Summary of Reactogenicity/Injection Site Inspection  
(Safety Population)  
 
IM Route 
 
SQ Route 
 
CD388 
50 mg 
(N = 
XX)  
CD388 
150 mg 
(N = 
XX) 
CD388 
450 mg 
(N = 
XX) 
Pooled 
Placebo 
(N = 
XX)  
 CD388 
50 mg 
(N = 
XX) 
CD388 
150 mg 
(N = 
XX) 
CD388 
450 mg 
(N = 
XX) 
CD388 
900 mg 
(N = 
XX) 
 
ETC. 
(N = XX) 
 
 
 
 
 
 
 
 
 
 
 
Subject With at Least One Injection Site 
Reaction [n(%)] 
 
 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Injection Site XX 
Grade 1 
 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx 
(xx.x) 
Xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
 
 
Program Source: xxx.sas 
 
IM = Intramuscular; SQ = Subcutaneous. 
Note: Baseline is the measurement of the last predose measurement was used. 
<Programming Note> 
ETC.= for SQ:  Cohort 4B CD388 – Pooled Placebo 
It can be presented separately (i.e., IM one page and SQ another). 
 
 


 
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FIGURE MOCK SHELLS 
The templates indicate the content that will be presented in the figures. The appearance, e.g., the actual time points or values, the 
layout of the figure, fonts, or other typographic detail, may be different in the final versions of the figures. 
 
 


 
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Table 14.2.27 
Template F1: Mean (+SD) Concentration-Time Profile – Plasma (PK Population) 
Figure 14.2.1.1.1.x.y 
Mean (+SD) Plasma CD388 Concentration-Time Profiles Following a Single <ADMIN> of CD388 to Healthy Subjects <SCALE> 
 
x = 1 for Intramuscular Injection, 2 for Subcutaneous Injection 
x= <ADMIN>; y=<SCALE> 
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<SCALE> = Linear or Semi-logarithmic 
Note: Semi-logarithmic figure will also be presented. 3 (IM) or 4 (SQ) cohorts will be included in these figures. Time scale will 
be adjusted to match data. 
Programming Note: 


 
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Figure 14.2.1.1.2.x.y: “Mean (+SD) Plasma CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of CD388 to Healthy 
Subjects <SCALE>” will follow the same layout. 
 
Figure 14.2.2.1.1.x.y: “Mean (+SD) Nasopharyngeal CD388 Concentration-Time Profiles Following a Single <ADMIN> of CD388 to Healthy 
Subjects <SCALE>“ will follow the same layout. 
 
Figure 14.2.2.1.2.x.y: “Mean (+SD) Nasopharyngeal CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of CD388 to 
Healthy Subjects <SCALE>” will follow the same layout. 
 
 
 


 
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Table 14.2.28 
Template F2: Box-and-Whiskers Plot of Plasma CD388 <PKPARAM> – Plasma (PK Population) 
Figure 14.2.1.2.1.x.y 
Box-and-Whiskers Plot of Plasma CD388 <PKPARAM> Following a Single <ADMIN> of CD388 to Healthy Subjects 
 
x = 1 for Intramuscular Injection, 2 for Subcutaneous Injection 
y = 1 for Cmax,2 for AUC0-t, and 3 for AUC0-∞ for plasma or 1 for Cmax, and 2 for AUC0-t for nasopharyngeal 
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<PKPARAM> = Cmax, AUC0-t, and AUC0-∞ for plasma or Cmax, and AUC0-t for nasopharyngeal 
Note: 3 (IM) or 4 (SQ) cohorts will be included in these figures.  


 
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Programming Note: 
 
Figure 14.2.1.2.2.x.y: “Box-and-Whiskers Plot of Plasma CD388 <PKPARAM> Following a Single <ADMIN> of CD388 to Healthy Subjects” 
will follow the same layout. 
 
Figure 14.2.2.2.1.x.y: “Box-and-Whiskers Plot of Nasopharyngeal CD388 <PKPARAM> Following a Single <ADMIN> of CD388 to Healthy 
Subjects” will follow the same layout. 
 
Figure 14.2.2.2.2.x.y: “Box-and-Whiskers Plot of Nasopharyngeal CD388 <PKPARAM> Following a Repeated Single <ADMIN> of CD388 to 
Healthy Subjects” will follow the same layout. 
 
 
 


 
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Table 14.2.29 
Template F3: Individual Plasma CD388 Concentration-Time Profiles – (PK Population) 
 
Figure 16.2.6.1.7.x 
Individual Plasma CD388 Concentration-Time Profiles Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects  
(<COHORT>, Linear Scale) 
 
 
x = x = 1 through 7 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B 
<DOSE> = 50 mg, 150 mg, 450 mg and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Note: All subjects per cohort will be included in one figure. Time scale will be adjusted to match data. 
Programming Note: 


 
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Figure 16.2.6.1.8.x: “Individual Plasma CD388 Concentration-Time Profiles Following a Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>, Semi-Logarithmic Scale)” will follow the same layout. 
 
Figure: 16.2.6.1.9.x: “Individual Plasma CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>, Linear Scale)” will follow the same layout. 
 
Figure 16.2.6.1.10.x: “Individual Plasma CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>, Semi-Logarithmic Scale)” will follow the same layout. 
 
Figure 16.2.6.2.7.x.y: “Individual Nasopharyngeal CD388 Concentration-Time Profiles Following a Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>, Linear Scale)” will follow the same out. 
 
Figure 16.2.6.2.8.x.y: “Individual Nasopharyngeal CD388 Concentration-Time Profiles Following a Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>, Semi-Logarithmic Scale)” will follow the same out. 
 
Figure 16.2.6.2.9.x.y: “Individual Nasopharyngeal CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of <DOSE> 
CD388 to Healthy Subjects (<COHORT>, Linear Scale)” will follow the same layout. 
 
Figure 16.2.6.2.10.x.y: “Individual Nasopharyngeal CD388 Concentration-Time Profiles Following a Repeated Single <ADMIN> of <DOSE> 
CD388 to Healthy Subjects (<COHORT>, Semi-Logarithmic Scale)” will follow the same layout. 
 
 
 
 
 
 
 
 


 
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LISTING MOCK SHELLS 
The templates indicate the content that will be presented in the listings. The appearance, e.g., the layout of the table, fonts, or other 
typographic detail, may be different in the final versions of the outputs. 
Note: Additional visits could be added to present the data in the DB, where necessary (e.g. Early Termination / Unscheduled 
Visit). See the CRF and the protocol for more details. 
 
 
 


 
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Table 14.2.30 
Template L1: Randomization  
Listing 16.1.7 
Randomization 
Subject ID 
Route/Cohort 
Randomization Date 
Randomization Number 
Treatment 
 
 
 
 
 
xxxx 
 
DDMONYYYY 
xxxx 
xxx 
… 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
 


 
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Table 14.2.31 
Template L2: Subject Disposition (Safety Population) 
Listing 16.2.1 
Subject Disposition  
(Safety Population) 
 
 
 
 
Withdrawal 
Subject 
ID 
Route/Cohort/Treatment Completed 
Date of Completion or 
Withdrawal 
Primary Reason 
Last Day 
 
 
 
 
 
 
xxxx 
xxx 
Yes 
DDMONYYYY 
 
 
 
 
 
 
 
 
xxxx 
xxxx 
No 
DDMONYYYY 
Xxxxxxx 
Day xx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
Programming Note: If Primary Reason for Discontinuation is Adverse Event, include AE # and verbatim term. 
 
 
 


 
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Table 14.2.32 
Template L3.1: Protocol Deviations (Safety Population) 
Listing 16.2.2.1 
Protocol Deviations  
(Safety Population) 
Subject 
ID 
Deviation 
Reference 
ID 
Date 
Route/Cohort/Treatment 
 
 
Description 
of 
Protocol 
Deviation 
Classification Category 
Assessment 
Type 
 
 
 
 
 
 
 
 
 
xxxx 
xxxxx 
DDMONYYYY 
xxx 
 
 
Xxxxxxx 
Major 
Missed 
Procedures/Assessments 
Medical 
History 
 
xxxxx 
 
xxx 
 
 
xxxxxx 
Minor 
Order of 
Procedures/Assessments 
Demographics 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
 
 


 
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Table 14.2.33 
Template L3.2: Pharmacokinetic Blood Sample Deviations (Safety Population) 
Listing 16.2.2.2 
Pharmacokinetic Blood Sample Deviations  
(Safety Population) 
Route/Cohort/Treatment 
Visit 
Elapsed Time (h) 
Subject ID 
Deviation (min) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
 
IM = Intramuscular; SQ = Subcutaneous  
 


 
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Table 14.2.34 
Template L4.1: Inclusion/Exclusion Criteria Violations (Safety Population) 
Listing 16.2.3.1 
Inclusion/Exclusion Criteria Violations  
(Safety Population) 
Subject ID 
Visit Route/Cohort/Treatment 
Type 
Criterion 
Number 
Criterion 
Comment(s) 
 
 
 
 
 
 
 
xxxx 
xx 
Xx/xx 
Inclusion 
xx 
Xxxxxxx 
 
 
 
 
Exclusion 
xx 
Xxxxxxxxxx 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
Programming Note: The column “Comment(s)” may be removed if it is not populated. 
 
 
 


 
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Table 14.2.35 
Template L4.2: Analysis Population  
Listing 16.2.3.2 
Analysis Population  
 
Subject ID 
 
Route/Cohort/Treatment 
Enrolled 
Population 
Safety Population 
PK Population 
Reason for Exclusion 
from the PK 
Population 
 
 
 
 
xxxx 
xxx 
 
Yes 
Yes 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
Programming Note: If any of the Reason for Exclusion columns is not populated, they will be removed. 
 
 
 


 
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Table 14.2.36 
Template L5.1: Demographics and Informed Consent (Safety Population)  
Listing 16.2.4.1 
Demographics and Informed Consent 
(Safety Population) 
 
Subject 
ID 
Route/Cohort/
Treatment 
 
Informed 
Consent Date 
Sex 
Age 
(years) 
Race 
Ethnicity 
Height 
(cm) 
Weight 
(kg) 
BMI 
(kg/m2) 
 
 
 
 
 
 
 
 
 
 
 
xxxx 
xx 
 
DDMONYYYY 
Xxxx 
xx 
White 
Xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxx 
xx 
 
DDMONYYYY 
Xxxx 
xx 
Other: Specify 
Xxxxx 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
BMI = Body Mass Index; IM = Intramuscular; SQ = Subcutaneous 
Age at Informed Consent 
 
 


 
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Table 14.2.37 
Template L5.2: Medical History (Safety Population) 
Listing 16.2.4.2 
Medical History  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
MH 
# 
System Organ 
Class/ 
Preferred 
Term 
Medical/Surgical History Description 
Start Date 
End Date/ 
Ongoing 
 
 
 
 
 
 
xxxx 
xx 
x Xxxxxx/ Xxxxx Xxxxxxxxxxxx 
DDMONYYYY 
DDMONYYYY 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
MH = Medical History; IM = Intramuscular; SQ = Subcutaneous 
 


 
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Table 14.2.38 
Template L5.3: Prior and Concomitant Medications (Safety Population) 
Listing 16.2.4.3 
Prior and Concomitant Medications  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
Treatment 
Date and 
Time 
CM # 
P/C/PC 
Drug Class/ 
Preferred Term/ 
Verbatim Text 
Dosing 
Information* 
Start Date (Day)** 
and Time/ 
Stop Date (Day)** 
and Time/ Ongoing 
Indication/ 
Administered for 
AE?/ AE Number / 
Preferred Term 
 
 
 
 
 
 
 
 
xxxx 
xx 
DDMONYYYY 
HH:MM 
x 
C 
Analgesics/ 
Paracetamol/ 
Tylenol 
xxx/ mg/ 
Once/ Oral 
DDMONYYYY (xx) 
HH:MM/ DDMONYYYY 
(xx) HH:MM 
Headache/ Yes/ AE # 
4/ Headache 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
C = Concomitant; P = Prior; PC = Prior and Concomitant; CM = Concomitant Medication; IM = Intramuscular; SQ = Subcutaneous   
*Dose/ Unit/ Frequency/ Route 
**Start and stop day are relative to Day 1. 
Notes: Prior and concomitant medications are coded into drug class and preferred term using WHODrug September 1, 2021. 
Prior medications are identified as medications started within 30 days before screening and prior to the administration of 
investigational product. Concomitant medications are identified as medications taken following administration of IP. 
 
 


 
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Table 14.2.39 
Template L6.1: Investigational Product Administration (Safety Population) 
Listing 16.2.5.1 
Investigational Product Administration – First Dose 
(Safety Population) 
Subjec
t ID 
Administratio
n Day 
Route/Cohort/Treatmen
t 
Date 
Time 
(HH:MM
) 
Was the 
treatment 
administered
? 
Dose 
(Unit
) 
 
Rout
e 
Injectio
n Site 
Number 
Anatomica
l 
Location 
Other, 
Specif
y 
Side (From 
Subject’s 
Perspective
) 
Directionalit
y 
 
 
 
 
 
 
 
xxxx xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
Yes 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
Xx/xx 
DDMONYYY
Y 
HH:MM 
xx 
xx  xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IM = Intramuscular; SQ = Subcutaneous 
Programming Note: The column “Dosing Comment(s)” may be removed if it is not populated. 
Listing 16.2.5.2: “Investigational Product Administration – Second Dose” will follow the same layout. 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 


 
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Table 14.2.40 
Template L7.1: Individual Plasma CD388 Pharmacokinetic Data (PK Population) 
Listing 16.2.6.1.1.x 
Individual Plasma CD388 Concentration Data Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>) 
 
  
Time 
(h)  
0 
2 
4 
12 
24 
48 
72 
… 
696 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
Subject 
Concentration 
(Units) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Lower Limit of Quantitation is xx.x (Units) 
NC: Not Calculated, NS: No Sample 
 
x = 1 through 7 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B 
<DOSE> = 50 mg, 150 mg, 450 mg and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note: 
Listing 16.2.6.1.2.x: “Individual Plasma CD388 Concentration Data Following a Repeated Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.1.x: “Individual Nasopharyngeal CD388 Concentration Data Following a Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.2.x: “Individual Nasopharyngeal CD388 Concentration Data Following a Repeated Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>)” will follow the same layout. 
 
 
 


 
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Table 14.2.41 
Template L7.2: Individual Urine Concentration Data (PK Population) 
Listing 16.2.6.1.3.x 
Individual Urine <ANALYTE> Concentration Data Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>) 
 
  
Interval 
(Units)  
0 - 12 
12 - 24 
24 - 48 
312 - 336 
… 
672 - 696 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
Subject 
Concentration 
(Units) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Lower Limit of Quantitation is xx.x (Units) 
NC: Not Calculated, NS: No Sample 
 
x = 1 through 7 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B 
<ANALYTE> = free zanamivir, zanamivir dimers 
<DOSE> = 50 mg, 150 mg, 450 mg and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note: 
Listing 16.2.6.1.3.1: “Individual Urine Free Zanamivir Concentration Data Following <ADMIN> of <DOSE> CD388 to Healthy Subjects 
(<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.3.2: “Individual Urine Zanamivir Dimers Concentration Data Following <ADMIN> of <DOSE> CD388 to Healthy Subjects 
(<COHORT>)” will follow the same layout. 
 
 


 
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Table 14.2.42 
Template L7.3: Individual Plasma CD388 Pharmacokinetic Parameters (PK Population) 
Listing 16.2.6.1.4.x 
Individual Plasma CD388 Pharmacokinetic Parameter Estimates Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>) 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
Subject 
Cmax  
(Unit) 
Tmax 
(Unit) 
AUC0-t 
(Unit) 
… 
Vz/F  
(Unit) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
NC: Not Calculated 
 
x = 1 through 7 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B 
<DOSE> = 50 mg, 150 mg, 450 mg, and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note: 
Listing 16.2.6.1.5.x: “Individual Plasma CD388 Pharmacokinetic Parameter Estimates Following a Repeated Single <ADMIN> of <DOSE> CD388 
to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.4.x: “Individual Nasopharyngeal CD388 Pharmacokinetic Parameter Estimates Following a Single <ADMIN> of <DOSE> CD388 
to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.5.x: “Individual Nasopharyngeal CD388 Pharmacokinetic Parameter Estimates Following a Repeated Single <ADMIN> of 
<DOSE> CD388 to Healthy Subjects (<COHORT>)” will follow the same layout. 
 
 
 


 
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Table 14.2.43 
Template L7.4: Actual Pharmacokinetic Plasma Sampling Times (PK Population) 
Listing 16.2.6.1.6.x 
Actual Pharmacokinetic Plasma Sampling Times Following a Single <ADMIN> of <DOSE> CD388 to Healthy Subjects (<COHORT>) 
 
  
Time 
(h)  
0 
2 
4 
12 
24 
48 
72 
…. 
696 
Cohort 
Route of 
Administration 
CD388 
Dose  
(mg) 
Subject 
Actual Time 
(h) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
NS: No Sample 
 
x = 1 through 7 for Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B 
<DOSE> = 50 mg, 150 mg, 450 mg, and 900 mg for Cohorts 1A/1B, 2A/2B, 3A/3B, and 4B, respectively.  
<ADMIN> = Intramuscular Injection for Cohorts 1A, 2A, and 3A or Subcutaneous Injection for Cohorts 1B, 2B, 3B, and 4B.  
<COHORT> = Cohorts 1A, 1B, 2A, 2B, 3A, 3B, and 4B.  
Programming Note: 
Listing 16.2.6.1.7.x: “Actual Pharmacokinetic Plasma Sampling Times Following a Repeated Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.6.x: “Actual Pharmacokinetic Nasopharyngeal Sampling Times Following a Single <ADMIN> of <DOSE> CD388 to Healthy 
Subjects (<COHORT>)” will follow the same layout. 
 
Listing 16.2.6.2.7.x: “Actual Pharmacokinetic Nasopharyngeal Sampling Times Following a Repeated Single <ADMIN> of <DOSE> CD388 to 
Healthy Subjects (<COHORT>)” will follow the same layout. 
 
 
 


 
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Table 14.2.44 
Template L7.5: Anti-Drug Antibodies (Safety Population) 
Listing 16.2.6.2 
Anti-Drug Antibodies 
(Safety Population) 
Subject ID 
Route/Cohort 
/Treatment 
Timepoint 
Results 
Actual Date/ Time Not Done 
 
 
 
 
 
 
xxxx 
xx 
xx.x 
xxx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Table 14.2.45 
Template L8: Adverse Events (Safety Population) 
Listing 16.2.7.1 
Adverse Events  
(Safety Population) 
Subject 
ID 
Onset 
Day* 
Route/Cohort 
/Treatment 
AE 
#/TEA
E 
 
System Organ Class/ 
Preferred Term/ 
Verbatim Term 
Start 
Date and 
Time/ 
End Date 
and Time 
Time from 
Dosing**/ 
Duration 
(DD:HH:MM) 
Severity/ 
Serious AE/ 
Relationship 
to Study 
Drug/ 
Outcome 
Study Drug Action Taken/ 
Other Action Taken/CM 
Administered?/CM 
Number/CM Preferred Term 
 
 
 
 
 
 
 
 
 
xxxx 
xx 
xx 
xx 
Xxxxxxxxxxxxxxxxxx/ 
Xxxxxxxxxxxxxxxxxxxxx
/ xxxxxxxxx 
DDMONYYY
Y HH:MM/ 
DDMONYYY
Y HH:MM 
DD:HH:MM/ 
DD:HH:MM 
Mild/ 
Expected/No/ 
Probable/ 
xxxxx 
xxxxxxxxxxxxxxxxxx/ 
Subject withdrawn 
 
 
 
xx 
Xxxxxxxxxxxxxxxxxxxx/ 
Xxxx xxxxxxxxxxx/ 
Xxxxxxxxxxxxxx  
DDMONYYY
Y HH:MM/ 
DDMONYYY
Y  
DD:HH:MM/ 
DD days 
xxxx/ xxxx/ 
Yes - 
Reason(s)/ 
Xxxx/ 
xxxxxxxxx 
xxxxxxxxxxxxxxx/No/Yes/C
M # 2/ Paracetamol 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
AE = Adverse Event, CM = Concomitant Medication; IM = Intramuscular; SQ = Subcutaneous;  
*Onset day is relative to Day 1. 
**Time from dosing is relative to treatment date. 
Notes: A Treatment-Emergent Adverse Event (TEAE) is an adverse event which starts or worsens after treatment with study drug.  If the 
start date or time is missing then the AE is considered to be a TEAE, unless the information available implies otherwise. Depending 
where a TEAE occurred, relationship was clinically assessed in terms of treatment. 
Adverse events are coded into system organ class and preferred term using MedDRA Version 24.1. 


 
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Table 14.2.46 
Template L9.1: <Laboratory Panel> (Safety Population) 
Listing 16.2.8.1.x 
<Laboratory Panel>  
(Safety Population) 
Subject 
ID 
Parameter 
(Unit) 
Route/Cohort/Treatment Visit 
Result 
High/Low 
Flag 
Clinical Significance 
PCS 
Flag 
Reason Not 
Done  
 
 
 
 
 
 
 
 
 
xxxx 
Xxxxxxx (unit)  xx 
Screening 
x.x 
 
Clinically Significant 
 
 
 
 
 
Day xx 
x.x 
High 
Not Clinically 
Significant 
 
 
 
 
 
Day xx 
x.x 
 
 
 
 
 
 
 
Day x 
x.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous ; PCS = Potentially Clinically Significant 
<Laboratory Panel> = Hematology; Chemistry; Urinalysis, Coagulation, Lipids 
Programming Note: The column “Reason Not Done/Comments” may be removed if it is not populated. 


 
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Table 14.2.47 
Template L9.2: Serology (Safety Population) 
Listing 16.2.8.1.6 
Serology  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
Visit 
SARS-CoV-2 
(PCR) 
HIV Antibody 
Hepatitis 
B 
Surface 
Antigen (HBsAg) 
Hepatitis C Antibody 
 
 
 
 
 
 
 
xxxx 
xxx 
xxx 
 
 
Negative 
Negative 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous; HIV = Human Immunodeficiency Virus; SARS-CoV-2 = Severe Acute Respiratory Syndrome Coronavirus 
2; PCR = Polymerase Chain Reaction 
 


 
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Table 14.2.48 
Template L9.3: Urine Drugs of Abuse Screen (Safety Population) 
Listing 16.2.8.1.5.1 
Urine Drugs of Abuse Screen  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatm
ent 
Visit 
Alcoho
l 
Amphetami
ne 
Barbiturat
es 
Benzodiazepin
es 
Cannabinoi
ds 
Cocain
e 
Cotini
ne 
 
Methamphetami
ne 
Opiate 
 Oxycodone 
Phencyclidin
e 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxx 
xx 
Screeni
ng 
Negati
ve 
Negative Negative 
Negative 
Negative 
Negati
ve 
Negati
ve 
 
Negative 
Negati
ve 
 Negative 
Negative 
 
 
Day xx 
Negati
ve 
Negative Negative 
Negative 
Negative 
Negati
ve 
Negati
ve 
 
Negative 
Negati
ve 
 Negative 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 


 
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Listing 16.2.8.1.5.2 
Urine Samples  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
Visit 
Start Time 
End Time 
Sample Volume 
 
 
 
 
 
 
xxxx 
xx 
Screening 
 
 
 
 
 
Day xx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
 
Abbreviation(s) : IM = Intramuscular; SQ = Subcutaneous 
 
 


 
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Table 14.2.49 
Template L9.4: Pregnancy Test (Safety Population) 
Listing 16.2.8.1.6 
Serum Pregnancy Test  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
Visit 
Date and Time of Assessment 
Lab Test 
Specimen Type 
Result 
 
 
 
 
 
 
 
xxxx 
xx 
Screening 
DDMONYYYY HH:MM 
 
 
 
 
 
Day xx 
DDMONYYYY HH:MM 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous; 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 14.2.50 
Template L9.5: FSH Test (Safety Population) 


 
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Listing 16.2.8.1.7 
Follicle Stimulating Hormone Testing  
(Safety Population) 
Subjec
t 
ID 
Parameter (Units) 
Route/Cohort/Treatment Visit 
Result 
High/Low Flag 
Clinical 
Significance 
 
 
 
 
 
 
 
 
 
xxxx 
Follicle Stimulating 
Hormone (mIU/mL) 
xx 
Screening 
 
 
 
 
 
 
 
Day xx 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
 
 


 
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Table 14.2.51 
Template L10.1: Vital Signs (Safety Population) 
Listing 16.2.8.2.1 
Vital Signs  
(Safety Population) 
Subject 
ID 
<Parameter 
(Unit)> 
Route/Cohort
/Treatment 
Visit 
Time 
Point 
Date and 
Time of 
Assessment 
Result 
Investigator’s 
Evaluation 
PCS Flag/ 
Time 
Occurrence 
after 
Dosing 
(DD:HH:MM) 
Reason 
Not 
Done/ 
Comments 
 
 
 
 
 
 
 
 
 
 
xxxx 
Xxxxxxx 
(unit) 
 
Screening 
 
DDMONYYYY 
HH:MM 
x.x 
Normal 
xx 
xx 
 
 
 
Day xx 
 
DDMONYYYY 
HH:MM 
x.x 
Abnormal - 
Clinically 
Significant 
xx 
xx 
 
 
 
Day x 
 
DDMONYYYY 
HH:MM 
x.x 
Normal 
xx 
xx 
 
 
 
Day xx 
 
DDMONYYYY 
HH:MM 
x.x 
Normal 
xx 
xx 
 
 
 
Day xx 
Predose 
DDMONYYYY 
HH:MM 
x.x 
Normal 
xx 
xx 
 
 
 
 
xx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
CS = Clinically Significant; DBP = Diastolic Blood Pressure; NCS = Not Clinically Significant; SBP = Systolic Blood Pressure; IM =    
Intramuscular; SQ = Subcutaneous; PCS = Potentially Clinically Significant. 
<Parameter (unit)> = Systolic Blood Pressure, (mmHg) Diastolic Blood Pressure (mmHg), Pulse Rate (beats/min), Temperature (C),   
Respiratory Rate (breaths/min) 
Programming Notes: The column “Reason Not Done” will be removed if it is not populated. 


 
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Table 14.2.52 
Template L10.2: 12-Lead Electrocardiogram (ECG) (Safety Population) 
Listing 16.2.8.2.2 
12-Lead Electrocardiogram (ECG)  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment 
Visit 
Date and 
Time of 
Assessment 
Overall 
Interpretation 
Abnormal 
Findings 
HR 
(bpm) 
PR 
(msec) 
QRS 
(msec) 
QT 
(msec) 
QTcF 
(msec) 
Reason 
Not 
Done 
 
 
 
 
 
 
 
 
 
 
 
xxxx 
xxxx 
Screening 
DDMONYYYY 
HH:MM 
Normal 
 
xx 
xxx 
xx 
xxx 
xxx 
 
 
 
 
DDMONYYYY 
HH:MM 
Normal 
 
xx 
xxx 
xx 
xxx 
xxx 
 
 
 
 
DDMONYYYY 
HH:MM 
Normal 
 
xx 
xxx 
xx 
xxx 
xxx 
 
 
 
 
DDMONYYYY 
HH:MM 
Normal 
 
xx 
xxx 
xx 
xxx 
xxx 
 
 
 
Day xx 
DDMONYYYY 
HH:MM 
NCS 
Xxxxxx 
xx 
xxx 
xx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
CS = Clinically Significant; NCS = Not Clinically Significant; HR = Heart Rate; IM = Intramuscular; SQ = Subcutaneous 
Programming Note: The column “Reason Not Done” will be removed if it is not populated. 


 
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Table 14.2.53 
Template L10.4: Physical Examination (Safety Population) 
Listing 16.2.8.2.3 
Physical Examination  
(Safety Population) 
Subject 
ID 
Route/Cohort/Treatment Visit 
Date of 
Assessment Body System 
Result Abnormality  
Description  
 
 
 
 
 
 
 
xxxx 
xxxxx 
Screening 
DDMONYYYY Head and Neck 
NCS 
Xxxxxxxx 
 
 
 
 
Cardiovascular 
Normal  
 
 
 
 
Respiratory 
Normal  
 
 
 
 
Gastrointestinal Normal  
 
 
 
 
General 
Appearance 
Normal  
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Day xx 
DDMONYYYY Xxxxxx 
CS 
Xxxxxxxx 
 
 
… 
 
 
 
 
 
 
Day xx 
DDMONYYYY Xxxxxx 
CS 
Xxxxxxxx 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
CS = Clinically Significant; NCS = Not Clinically Significant; IM = Intramuscular; SQ = Subcutaneous 
 
 


 
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Table 14.2.54 
Template L10.5: Reactogenicity/Injection Site Inspection (Safety Population) 
Listing 16.2.8.2.4 
Reactogenicity/Injection Site Inspection  
(Safety Population) 
Subject ID 
Route/Cohort/Treatment Description 
Onset Date/Time 
(Time Since 
 Last Dose) 
Resolution 
Date/Time 
(Duration) 
Maximum 
Intensity/ 
Relatedness 
 
 
 
 
 
 
xxxx 
xxxxx 
 
DDMONYYYY 
 
Grade 
1/Related 
 
 
 
 
 
Grade 2/ 
Related 
 
 
 
 
 
Grade 3/ 
Related 
 
 
 
 
 
Grade 4/ 
Related 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Day xx 
DDMONYYYY 
Xxxxxx 
Xxxxxx 
 
 
… 
 
 
 
 
 
Day xx 
DDMONYYYY 
Xxxxxx 
Xxxxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Date: VERSION - YYYY-MM-DD 
Data Source: xxx 
Program Source: xxx.sas 
IM = Intramuscular; SQ = Subcutaneous 
Note(s): Time Since Last Dose is DAYS:HRS:MIN. Pain: Mild = Does not interfere with activity; Moderate = Repeated use of non-narcotic 
pain reliever >24 hours or interferes with activity; Severe = Any use of narcotic pain reliever or prevents daily activity; Life-
threatening = Emergency room (ER) visit or hospitalization. Tenderness: Mild = Mild discomfort to touch; Moderate = Discomfort with 
movement; Severe = Significant discomfort at rest; Life-threatening = ER visit or hospitalization. Erythema/Redness: Mild = 2.5–5 cm; 
Moderate = 5.1–10 cm; Severe = >10 cm; Life-threatening = Necrosis or exfoliative dermatitis. Induration/Swelling: Mild = 2.5–5 cm and 
does not interfere with activity; Moderate = 5.1–10 cm or interferes with activity; Severe = >10 cm or prevents daily activity; Life-
threatening = Necrosis. 
 


 
Research Project No. CID-P1-144 | Sponsor Protocol No. CD388.IM.SQ.1.01 | Version Final Amendment 3.0 | 2023-12-20 
Page 125 of 125 
 


Certificate Of Completion
Envelope Id: A85095FE5B814DA0AA2686682369B6DB
Status: Completed
Subject: Complete with DocuSign: CD388.IM.SQ.1.01 (CID-P1-144) SAP and Shell Amendment_v3.0_Final_20Dec2...
Source Envelope: 
Document Pages: 125
Signatures: 3
Envelope Originator: 
Certificate Pages: 3
Initials: 0
Monica Sanford
AutoNav: Enabled
EnvelopeId Stamping: Disabled
Time Zone: (UTC-08:00) Pacific Time (US & Canada)
6310 Nancy Ridge Dr
STE 101
San Diego, CA  92121
msanford@cidara.com
IP Address: 73.119.216.193 
Record Tracking
Status: Original
             12/20/2023 7:59:04 PM
Holder: Monica Sanford
             msanford@cidara.com
Location: DocuSign
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Dinh Truong Bui
dbui@altasciences.com
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(Required), Logged in
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Signature ID: 
C782E657-3A8F-40ED-A255-3D4BCF8D6582
Using IP Address: 75.45.52.171
With Signing Authentication via DocuSign password
With Signing Reasons (on each tab): 
   I approve this document
Sent: 12/20/2023 8:31:11 PM
Viewed: 12/21/2023 3:06:28 AM 
Signed: 12/21/2023 3:54:55 AM
Electronic Record and Signature Disclosure: 
      Accepted: 12/21/2023 3:06:28 AM
      ID: 9f3dbbff-af16-4201-850b-e440bc945fe8
Haleh Aghamolaey
haghamolaey@altasciences.com
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(Required)
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Signature ID: 
3CE94D04-4676-4AE6-9174-63589CD50777
Using IP Address: 130.41.10.187
With Signing Authentication via DocuSign password
With Signing Reasons (on each tab): 
   I am the author of this document
Sent: 12/20/2023 8:31:10 PM
Viewed: 12/20/2023 8:32:02 PM 
Signed: 12/20/2023 8:35:03 PM
Electronic Record and Signature Disclosure: 
      Accepted: 9/21/2023 7:51:52 AM
      ID: 3dd0bb06-96fa-4b70-8da3-cd5341df247e


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Ozlem Equils
oequils@cidara.com
Ozlem Equils
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(Required)
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Signature ID: 
8C319F80-E19A-475B-8904-4981B91CEB55
Using IP Address: 104.28.123.163
Signed using mobile
With Signing Authentication via DocuSign password
With Signing Reasons (on each tab): 
   I approve this document
Sent: 12/20/2023 8:31:11 PM
Viewed: 12/20/2023 8:45:53 PM 
Signed: 12/20/2023 8:46:21 PM
Electronic Record and Signature Disclosure: 
      Accepted: 12/20/2023 8:45:53 PM
      ID: d3e392d1-d9a2-4b56-977c-2e3a8b6ef16a
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Joaquin Sosa
jsosa@cidara.com
Director, Clinical Systems & Trial Management
Cidara Therapeutics
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(Required)
Sent: 12/20/2023 8:31:12 PM
Viewed: 12/21/2023 6:39:53 AM 
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Electronic Record and Signature Disclosure


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. 
2. I am to be held responsible for all actions initiated under my electronic signature. 
3. I will use my electronic signature only for those assigned tasks that I have the education, 
training, and experience to perform. 
I will comply with the US FDA 21 CFR Part 11 and EU Annex 11 security rules for Cidara 
Therapeutics use of electronic signatures as follows:  
1. I will not share passwords and/or identification codes used to log into a system or to 
manifest an electronic signature for Cidara Therapeutics documents. 
2. I will immediately notify Cidara Therapeutics of any loss of misuse of passwords and/or 
identification codes which may have been used to log into a system or to manifest an 
electronic signature for Cidara Therapeutics documents. 
Electronic Record and Signature Disclosure created on: 3/10/2021 10:22:11 AM
Parties agreed to: Dinh Truong Bui, Haleh Aghamolaey, Ozlem Equils