Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05285137

Enrollment

Registered

2022-03-17

Start date

2022-03-14

Completion date

2023-10-27

Last updated

2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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

Interventions

COMBINATION_PRODUCTCD388 Injection

CD388 liquid for injection

DRUGSaline placebo

Sterile normal saline for injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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: 1. If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of \<1 percent 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 include: abstinence from heterosexual intercourse; hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or without hormones); or a double barrier method (e.g., condom and spermicide). 2. 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 milli-International units \[mIU\]/milliliter \[mL\]). 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: 1. No physical examination findings that an Investigator determines would interfere with interpretation of study results. 2. Screening ECG without clinically significant abnormalities. 3. Creatinine clearance (CrCL) ≥80 mL/minute as calculated using the Cockcroft-Gault equation. 4. Negative urine screen for drugs of abuse and alcohol at screening and Day -1. 8. Body mass index (BMI; weight in kilograms \[kg\] divided by height in meters \[m\] squared) between 18.0 and 32.0 kg/m\^2, 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

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: 1. Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene glycol \[PEG\], etc.). 2. Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases. 3. Atopic dermatitis or psoriasis. 4. Bleeding disorder. 5. Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental conditions. 6. Migraines. 7. Syncope, or vasovagal syndrome with injections or blood draws. 8. Cardiac arrhythmia. 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): 1. Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal \[ULN\]) 2. Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN) 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 (≥1.25 × ULN) 4. Total bilirubin, Grade ≥1 (≥1.1 × ULN) 5. Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, low density lipoprotein cholesterol, and/or total cholesterol. 6. 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 clinical research unit (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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)	Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Severity of TEAEs After a Single Dose of CD388	Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)	Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.

Secondary

Measure	Time frame	Description
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Median Apparent Clearance (CL/F) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following the first single dose of CD388 administered by either IM or SQ injection.
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following the first single dose of CD388 administered by either IM or SQ injection.
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following the first single dose of CD388 administered by either IM or SQ injection.
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the apparent volume of distribution (V\[z\]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the apparent volume of distribution (V\[z\]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)	Number of participants with at least one TEAE, including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Severity of TEAEs After a Repeated Single Dose of CD388	Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)	Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)	Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)	Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.

Countries

United States

Participant flow

Recruitment details

A total of 77 participants were enrolled in the study at a single center, 33 of whom were randomized to receive study drug via intramuscular (IM) administration and 44 of whom were randomized to receive study drug via subcutaneous (SQ) administration.

Participants by arm

Arm	Count
CD388 50 mg IM Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	8
CD388 150 mg IM Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose. CD388: CD388 liquid for injection	8
CD388 450 mg IM Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose. CD388: CD388 liquid for injection	8
Pooled Placebo IM Participants randomized to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM and CD388 450 mg IM arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose. Saline placebo: Sterile normal saline for injection	9
CD388 50 mg SQ Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	8
CD388 150 mg SQ Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose. CD388: CD388 liquid for injection	8
CD388 450 mg SQ Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose. CD388: CD388 liquid for injection	8
CD388 900 mg SQ Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	8
Pooled Placebo SQ Participants randomized to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ and CD388 450 mg SQ arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose. Saline placebo: Sterile normal saline for injection	12
Total	77

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003	FG006	FG008
Overall Study	Failure to Meet Continuation Criteria	0	0	0	2	1
Overall Study	Lost to Follow-up	0	1	3	1	0
Overall Study	Physician Decision	1	0	0	0	0
Overall Study	Pregnancy	0	0	0	1	0
Overall Study	Withdrawal by Subject	1	2	1	0	1

Baseline characteristics

Characteristic	CD388 900 mg SQ	CD388 50 mg IM	CD388 150 mg IM	CD388 450 mg IM	Pooled Placebo IM	CD388 50 mg SQ	CD388 150 mg SQ	CD388 450 mg SQ	Pooled Placebo SQ	Total
Age, Continuous	34.0 years	37.0 years	38.5 years	32.5 years	30.0 years	45.5 years	30.5 years	35.5 years	37.5 years	35.0 years
Body Mass Index	27.78 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 2.606	27.10 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.033	26.78 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 2.69	25.90 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.502	27.02 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.609	27.29 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.311	27.11 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.74	28.64 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 2.978	26.05 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.345	27.02 kilograms/meter^2 (kg/m^2) STANDARD_DEVIATION 3.163
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants	8 Participants	5 Participants	7 Participants	9 Participants	8 Participants	7 Participants	7 Participants	12 Participants	71 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Height	176.75 centimeters	179.00 centimeters	173.50 centimeters	176.00 centimeters	177.00 centimeters	173.38 centimeters STANDARD_DEVIATION 11.975	174.00 centimeters	169.50 centimeters	171.50 centimeters	175.00 centimeters
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	7 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	6 Participants	5 Participants	8 Participants	43 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) White	1 Participants	5 Participants	4 Participants	4 Participants	3 Participants	4 Participants	2 Participants	3 Participants	4 Participants	30 Participants
Sex: Female, Male Female	1 Participants	1 Participants	4 Participants	1 Participants	5 Participants	3 Participants	1 Participants	2 Participants	5 Participants	23 Participants
Sex: Female, Male Male	7 Participants	7 Participants	4 Participants	7 Participants	4 Participants	5 Participants	7 Participants	6 Participants	7 Participants	54 Participants
Weight	86.30 kilograms (kg) STANDARD_DEVIATION 10.079	86.19 kilograms (kg) STANDARD_DEVIATION 5.68	79.53 kilograms (kg) STANDARD_DEVIATION 11.945	79.51 kilograms (kg) STANDARD_DEVIATION 16.157	79.97 kilograms (kg) STANDARD_DEVIATION 12.596	83.15 kilograms (kg) STANDARD_DEVIATION 19.835	81.03 kilograms (kg) STANDARD_DEVIATION 17.053	85.28 kilograms (kg) STANDARD_DEVIATION 16.085	76.73 kilograms (kg) STANDARD_DEVIATION 13.775	81.70 kg

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 8	0 / 8	0 / 9	0 / 8	0 / 8	0 / 8	0 / 8	0 / 12
other Total, other adverse events	5 / 8	5 / 8	6 / 8	8 / 9	5 / 8	4 / 8	6 / 8	3 / 8	7 / 12
serious Total, serious adverse events	0 / 8	0 / 8	0 / 8	0 / 9	0 / 8	0 / 8	0 / 8	0 / 8	0 / 12

Outcome results

Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388

Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.

Time frame: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)

Population: The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 \[IM route\], 44 \[SQ route\]).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CD388 50 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	5 Participants
CD388 50 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 150 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	5 Participants
CD388 150 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 450 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	5 Participants
CD388 450 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
Pooled Placebo IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	8 Participants
Pooled Placebo IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 50 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	5 Participants
CD388 50 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 150 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 150 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	4 Participants
CD388 450 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	2 Participants
CD388 450 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	5 Participants
CD388 900 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	3 Participants
CD388 900 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
Pooled Placebo SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with at least one TEAE	7 Participants
Pooled Placebo SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants

Primary

Severity of TEAEs After a Single Dose of CD388

Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.

Time frame: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)

Population: The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 \[IM route\], 44 \[SQ route\]).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CD388 50 mg IM	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
CD388 50 mg IM	Severity of TEAEs After a Single Dose of CD388	Moderate	0 Participants
CD388 50 mg IM	Severity of TEAEs After a Single Dose of CD388	Mild	5 Participants
CD388 150 mg IM	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
CD388 150 mg IM	Severity of TEAEs After a Single Dose of CD388	Moderate	0 Participants
CD388 150 mg IM	Severity of TEAEs After a Single Dose of CD388	Mild	5 Participants
CD388 450 mg IM	Severity of TEAEs After a Single Dose of CD388	Moderate	3 Participants
CD388 450 mg IM	Severity of TEAEs After a Single Dose of CD388	Mild	2 Participants
CD388 450 mg IM	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
Pooled Placebo IM	Severity of TEAEs After a Single Dose of CD388	Moderate	2 Participants
Pooled Placebo IM	Severity of TEAEs After a Single Dose of CD388	Mild	5 Participants
Pooled Placebo IM	Severity of TEAEs After a Single Dose of CD388	Severe	1 Participants
CD388 50 mg SQ	Severity of TEAEs After a Single Dose of CD388	Mild	4 Participants
CD388 50 mg SQ	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
CD388 50 mg SQ	Severity of TEAEs After a Single Dose of CD388	Moderate	1 Participants
CD388 150 mg SQ	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
CD388 150 mg SQ	Severity of TEAEs After a Single Dose of CD388	Mild	4 Participants
CD388 150 mg SQ	Severity of TEAEs After a Single Dose of CD388	Moderate	0 Participants
CD388 450 mg SQ	Severity of TEAEs After a Single Dose of CD388	Mild	3 Participants
CD388 450 mg SQ	Severity of TEAEs After a Single Dose of CD388	Severe	1 Participants
CD388 450 mg SQ	Severity of TEAEs After a Single Dose of CD388	Moderate	1 Participants
CD388 900 mg SQ	Severity of TEAEs After a Single Dose of CD388	Moderate	0 Participants
CD388 900 mg SQ	Severity of TEAEs After a Single Dose of CD388	Mild	3 Participants
CD388 900 mg SQ	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
Pooled Placebo SQ	Severity of TEAEs After a Single Dose of CD388	Moderate	1 Participants
Pooled Placebo SQ	Severity of TEAEs After a Single Dose of CD388	Severe	0 Participants
Pooled Placebo SQ	Severity of TEAEs After a Single Dose of CD388	Mild	6 Participants

Secondary

Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388

Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Population: The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00923 liters/hour (L/h)	Standard Deviation 0.00123
CD388 150 mg IM	Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00886 liters/hour (L/h)	Standard Deviation 0.0017
CD388 450 mg IM	Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00802 liters/hour (L/h)	Standard Deviation 0.00218
Pooled Placebo IM	Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00897 liters/hour (L/h)	Standard Deviation 0.0021

Secondary

Mean Apparent Clearance (CL/F) Following a Single Administration of CD388

Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.

Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

Population: The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00751 liters/hour (L/h)	Standard Deviation 0.00119
CD388 150 mg IM	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00867 liters/hour (L/h)	Standard Deviation 0.00177
CD388 450 mg IM	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00766 liters/hour (L/h)	Standard Deviation 0.00199
Pooled Placebo IM	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00900 liters/hour (L/h)	Standard Deviation 0.0023
CD388 50 mg SQ	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00725 liters/hour (L/h)	Standard Deviation 0.00123
CD388 150 mg SQ	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00883 liters/hour (L/h)	Standard Deviation 0.00213
CD388 450 mg SQ	Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00863 liters/hour (L/h)	Standard Deviation 0.00158

Secondary

Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388

Evaluation of the apparent volume of distribution (V\[z\]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	17.4 liters (L)	Standard Deviation 1.85
CD388 150 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	17.8 liters (L)	Standard Deviation 5.45
CD388 450 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	11.7 liters (L)	Standard Deviation 4.7
Pooled Placebo IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	16.7 liters (L)	Standard Deviation 3.55

Secondary

Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388

Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.3 liters (L)	Standard Deviation 1.91
CD388 150 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	14.8 liters (L)	Standard Deviation 4.4
CD388 450 mg IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	10.7 liters (L)	Standard Deviation 2.99
Pooled Placebo IM	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.4 liters (L)	Standard Deviation 2.59
CD388 50 mg SQ	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.3 liters (L)	Standard Deviation 3.7
CD388 150 mg SQ	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.1 liters (L)	Standard Deviation 2.61
CD388 450 mg SQ	Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	17.1 liters (L)	Standard Deviation 3.76

Secondary

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388

Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	16500 ug*h/mL	Standard Deviation 2530
CD388 150 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	52600 ug*h/mL	Standard Deviation 10800
CD388 450 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	20000 ug*h/mL	Standard Deviation 5830
Pooled Placebo IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	53400 ug*h/mL	Standard Deviation 17400

Secondary

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388

Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	6790 ug*h/mL	Standard Deviation 973
CD388 150 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	17900 ug*h/mL	Standard Deviation 3670
CD388 450 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	61800 ug*h/mL	Standard Deviation 13600
Pooled Placebo IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	5870 ug*h/mL	Standard Deviation 1470
CD388 50 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	21200 ug*h/mL	Standard Deviation 3670
CD388 150 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	54400 ug*h/mL	Standard Deviation 16900
CD388 450 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	107000 ug*h/mL	Standard Deviation 19700

Secondary

Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388

Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	14400 ug*h/mL	Standard Deviation 2050
CD388 150 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	41300 ug*h/mL	Standard Deviation 15400
CD388 450 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	18000 ug*h/mL	Standard Deviation 5090
Pooled Placebo IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	41100 ug*h/mL	Standard Deviation 21100

Secondary

Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388

Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-t\]) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	5450 ug*h/mL	Standard Deviation 728
CD388 150 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	15000 ug*h/mL	Standard Deviation 4320
CD388 450 mg IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	53800 ug*h/mL	Standard Deviation 12000
Pooled Placebo IM	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	4830 ug*h/mL	Standard Deviation 965
CD388 50 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	18800 ug*h/mL	Standard Deviation 3360
CD388 150 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	49000 ug*h/mL	Standard Deviation 13100
CD388 450 mg SQ	Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	96300 ug*h/mL	Standard Deviation 16700

Secondary

Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388

Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	10.5 micrograms/milliliter (ug/mL)	Standard Deviation 3.3
CD388 150 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	28.8 micrograms/milliliter (ug/mL)	Standard Deviation 7.66
CD388 450 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	13.0 micrograms/milliliter (ug/mL)	Standard Deviation 5.34
Pooled Placebo IM	Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	31.1 micrograms/milliliter (ug/mL)	Standard Deviation 7.86

Secondary

Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.

Population: The Pharmacokinetic (PK) Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	4.13 micrograms/milliliter (ug/mL)	Standard Deviation 0.747
CD388 150 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	10.4 micrograms/milliliter (ug/mL)	Standard Deviation 2.44
CD388 450 mg IM	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	48.6 micrograms/milliliter (ug/mL)	Standard Deviation 11.7
Pooled Placebo IM	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	3.57 micrograms/milliliter (ug/mL)	Standard Deviation 0.942
CD388 50 mg SQ	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	12.0 micrograms/milliliter (ug/mL)	Standard Deviation 3.35
CD388 150 mg SQ	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	32.7 micrograms/milliliter (ug/mL)	Standard Deviation 9.4
CD388 450 mg SQ	Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	58.8 micrograms/milliliter (ug/mL)	Standard Deviation 17.5

Secondary

Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388

Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1324.07 hours (h)	Standard Deviation 198.33
CD388 150 mg IM	Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1408.43 hours (h)	Standard Deviation 336.72
CD388 450 mg IM	Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1059.55 hours (h)	Standard Deviation 409.51
Pooled Placebo IM	Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1301.42 hours (h)	Standard Deviation 83

Secondary

Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388

Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1234.41 hours (h)	Standard Deviation 140.04
CD388 150 mg IM	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1192.03 hours (h)	Standard Deviation 235.8
CD388 450 mg IM	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1006.20 hours (h)	Standard Deviation 314.39
Pooled Placebo IM	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1069.78 hours (h)	Standard Deviation 216.48
CD388 50 mg SQ	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1265.53 hours (h)	Standard Deviation 223.93
CD388 150 mg SQ	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1065.21 hours (h)	Standard Deviation 239.19
CD388 450 mg SQ	Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1384.36 hours (h)	Standard Deviation 282.53

Secondary

Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388

Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	104.02 hours (h)	Standard Deviation 81.25
CD388 150 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	161.14 hours (h)	Standard Deviation 75.53
CD388 450 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	251.99 hours (h)	Standard Deviation 200.79
Pooled Placebo IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	105.02 hours (h)	Standard Deviation 49.89

Secondary

Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEAN)	Dispersion
CD388 50 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	111.08 hours (h)	Standard Deviation 72.42
CD388 150 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	159.03 hours (h)	Standard Deviation 83.1
CD388 450 mg IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	85.64 hours (h)	Standard Deviation 42.19
Pooled Placebo IM	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	213.00 hours (h)	Standard Deviation 108.43
CD388 50 mg SQ	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	137.48 hours (h)	Standard Deviation 77.82
CD388 150 mg SQ	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	120.04 hours (h)	Standard Deviation 67.83
CD388 450 mg SQ	Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	109.54 hours (h)	Standard Deviation 55.66

Secondary

Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388

Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00954 liters/hour (L/h)
CD388 150 mg IM	Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00918 liters/hour (L/h)
CD388 450 mg IM	Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00866 liters/hour (L/h)
Pooled Placebo IM	Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00946 liters/hour (L/h)

Secondary

Median Apparent Clearance (CL/F) Following a Single Administration of CD388

Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00707 liters/hour (L/h)
CD388 150 mg IM	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00851 liters/hour (L/h)
CD388 450 mg IM	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00726 liters/hour (L/h)
Pooled Placebo IM	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00834 liters/hour (L/h)
CD388 50 mg SQ	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00717 liters/hour (L/h)
CD388 150 mg SQ	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00912 liters/hour (L/h)
CD388 450 mg SQ	Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00870 liters/hour (L/h)

Secondary

Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	16.6 liters (L)
CD388 150 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	16.7 liters (L)
CD388 450 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	9.46 liters (L)
Pooled Placebo IM	Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	18.3 liters (L)

Secondary

Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388

Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.9 liters (L)
CD388 150 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	14.4 liters (L)
CD388 450 mg IM	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	10.9 liters (L)
Pooled Placebo IM	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	12.2 liters (L)
CD388 50 mg SQ	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	12.7 liters (L)
CD388 150 mg SQ	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	12.9 liters (L)
CD388 450 mg SQ	Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	16.7 liters (L)

Secondary

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	15700 ug*h/mL
CD388 150 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	49000 ug*h/mL
CD388 450 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	17300 ug*h/mL
Pooled Placebo IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	47600 ug*h/mL

Secondary

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	7080 ug*h/mL
CD388 150 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	17600 ug*h/mL
CD388 450 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	62100 ug*h/mL
Pooled Placebo IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	6000 ug*h/mL
CD388 50 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	21000 ug*h/mL
CD388 150 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	49300 ug*h/mL
CD388 450 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	103000 ug*h/mL

Secondary

Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	13600 ug*h/mL
CD388 150 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	41800 ug*h/mL
CD388 450 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	16000 ug*h/mL
Pooled Placebo IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388	39100 ug*h/mL

Secondary

Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	5460 ug*h/mL
CD388 150 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	15100 ug*h/mL
CD388 450 mg IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	52100 ug*h/mL
Pooled Placebo IM	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	4960 ug*h/mL
CD388 50 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	18700 ug*h/mL
CD388 150 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	46500 ug*h/mL
CD388 450 mg SQ	Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388	94700 ug*h/mL

Secondary

Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	9.94 micrograms/milliliter (ug/mL)
CD388 150 mg IM	Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	29.8 micrograms/milliliter (ug/mL)
CD388 450 mg IM	Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	12.5 micrograms/milliliter (ug/mL)
Pooled Placebo IM	Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	29.3 micrograms/milliliter (ug/mL)

Secondary

Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	3.96 micrograms/milliliter (ug/mL)
CD388 150 mg IM	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	10.4 micrograms/milliliter (ug/mL)
CD388 450 mg IM	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	48.0 micrograms/milliliter (ug/mL)
Pooled Placebo IM	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	3.72 micrograms/milliliter (ug/mL)
CD388 50 mg SQ	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	11.8 micrograms/milliliter (ug/mL)
CD388 150 mg SQ	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	31.6 micrograms/milliliter (ug/mL)
CD388 450 mg SQ	Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	60.7 micrograms/milliliter (ug/mL)

Secondary

Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1342.81 hours (h)
CD388 150 mg IM	Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1506.38 hours (h)
CD388 450 mg IM	Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1218.60 hours (h)
Pooled Placebo IM	Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1348.40 hours (h)

Secondary

MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388

Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1275.62 hours (h)
CD388 150 mg IM	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1285.85 hours (h)
CD388 450 mg IM	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1137.42 hours (h)
Pooled Placebo IM	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1052.39 hours (h)
CD388 50 mg SQ	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1270.40 hours (h)
CD388 150 mg SQ	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1040.30 hours (h)
CD388 450 mg SQ	MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1287.45 hours (h)

Secondary

Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388

Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	84.00 hours (h)
CD388 150 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	144.00 hours (h)
CD388 450 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	227.99 hours (h)
Pooled Placebo IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	96.00 hours (h)

Secondary

Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.

Arm	Measure	Value (MEDIAN)
CD388 50 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	96.07 hours (h)
CD388 150 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	131.98 hours (h)
CD388 450 mg IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	78.31 hours (h)
Pooled Placebo IM	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	228.00 hours (h)
CD388 50 mg SQ	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	131.28 hours (h)
CD388 150 mg SQ	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	96.00 hours (h)
CD388 450 mg SQ	Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	96.00 hours (h)

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388

Number of participants with at least one TEAE, including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.

Time frame: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)

Population: The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 \[IM route\], 44 \[SQ route\]).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CD388 50 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	2 Participants
CD388 50 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 150 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	4 Participants
CD388 150 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 450 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	2 Participants
CD388 450 mg IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
Pooled Placebo IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	2 Participants
Pooled Placebo IM	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 50 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	3 Participants
CD388 50 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants
CD388 150 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with at least one TEAE	1 Participants
CD388 150 mg SQ	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388	Participants with AEs leading to study withdrawal	0 Participants

Secondary

Severity of TEAEs After a Repeated Single Dose of CD388

Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.

Time frame: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)

Population: The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 \[IM route\], 44 \[SQ route\]).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CD388 50 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	0 Participants
CD388 50 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 50 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	2 Participants
CD388 150 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	2 Participants
CD388 150 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	2 Participants
CD388 150 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 450 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 450 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	2 Participants
CD388 450 mg IM	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	0 Participants
Pooled Placebo IM	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	2 Participants
Pooled Placebo IM	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	0 Participants
Pooled Placebo IM	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 50 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	0 Participants
CD388 50 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	3 Participants
CD388 50 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 150 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Mild	1 Participants
CD388 150 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Severe	0 Participants
CD388 150 mg SQ	Severity of TEAEs After a Repeated Single Dose of CD388	Moderate	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388

Severity of TEAEs After a Single Dose of CD388

Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388

Mean Apparent Clearance (CL/F) Following a Single Administration of CD388

Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388

Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388

Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388

Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388

Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388

Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388

Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388

Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388

Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388

Median Apparent Clearance (CL/F) Following a Single Administration of CD388

Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388

Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388

Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388

Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388

Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388

Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388

MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388

Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388

Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388

Severity of TEAEs After a Repeated Single Dose of CD388