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
Phase: PHASE1
Conditions: Healthy
Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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. 
 
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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  
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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. 
 
 

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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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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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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. 

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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. 

Cidara Therapeutics, Inc. 
 
 
Protocol CD388.IM.SQ.1.01 
CD388 Injection 
Amendment 2 
Confidential  
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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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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. 

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3. Positioning of the subject: Subjects in anaphylactic shock (i.e., those with anaphylaxis 
and signs of critical organ hypoperfusion) should be placed in a recumbent position with 
the lower extremities elevated unless precluded by shortness of breath or vomiting. 
4. Fluid resuscitation: Subjects who remain hypotensive despite epinephrine should have 
aggressive fluid resuscitation. Large volumes of crystalloid might be needed in the first 
5 to 10 minutes; in severe reactions with hypotension, up to 35% of the blood volume 
might extravasate in the first 10 minutes, and vasodilatation can cause pooling, with even 
more reduction in the effective blood volume and thus distributive shock. 
5. Vasopressors: Potent vasopressors, such as noradrenaline, vasopressin, or metaraminol, 
might be required to overcome vasodilatation if epinephrine and fluid resuscitation have 
failed to maintain a systolic blood pressure of greater than 90 mmHg. 
6. H1- and H2-antihistamines: Antihistamines (H1- and H2-antagonists) are slower in onset 
of action than epinephrine, have little effect on blood pressure, and should be considered 
a second-line treatment for anaphylaxis. 
7. Corticosteroids: Because the onset of action is slow, steroids are not useful in the acute 
management stage. It has been suggested that their use might prevent a protracted or 
biphasic reaction. 
8. 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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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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• 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. 

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• 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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• 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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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. 

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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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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 

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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: