CompletedNCT05285137Updated Feb 27, 2025Results posted

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

A Phase 1 interventional study of CD388 Injection and Saline placebo in Healthy, sponsored by Cidara Therapeutics Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Cidara Therapeutics Inc. · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 77
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Healthy

In context

Lead sponsor

Cidara Therapeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Willing and able to provide written informed consent.
Males and females 18 to 65 years of age, inclusive.
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]).
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.
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.
Good health and without signs or symptoms of current illness.
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.
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.
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.
Subject has adequate venous access for blood collection.

Exclusion criteria

Exclusion Criteria:

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]).
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.
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.
Alcohol or drug addiction in the past 2 years.
Experiencing symptoms of acute illness or chronic disease within 14 days prior to check-in to the clinical research unit (CRU).
At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
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.
Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 (COVID-19).*
Women who are pregnant or nursing.
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.
Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening.
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).**
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.
Received a blood transfusion within 28 days prior to dosing.
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.
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.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 77 participants (actual)

Study arms

Experimental
Cohort 1A (sentinel)
Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 1A (main)
Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 1B (sentinel)
Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 1B (main)
Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 2A (sentinel)
Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 2A (main)
Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 2B (sentinel)
Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 2B (main)
Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 3A (sentinel)
High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 3A (main)
High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 3B (sentinel)
High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 3B (main)
High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 4B (sentinel)
Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection · Drug: Saline placebo
Experimental
Cohort 4B (main)
Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection · Drug: Saline placebo

Interventions

Combination productCD388 Injection
CD388 liquid for injection
DrugSaline placebo
Sterile normal saline for injection

What researchers measure

Primary outcomes

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)
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)

Secondary outcomes

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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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)
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.
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)
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.
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)
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.
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)
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.
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)
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
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.
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)
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.
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)
Median 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.
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)
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)
Median 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)
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)
Median 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)
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)
Median 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)
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)
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)
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)
Median 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)
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)
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
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)
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)
Median 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)
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)
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)

Results

Posted Jan 24, 2025

Participant flow

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.

Participant flow — Overall Study
Milestone	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	CD388 900 mg SQ	Pooled Placebo SQ
Started	8	8	8	9	8	8	8	8	12
Completed	8	6	5	5	8	8	4	8	10
Not completed	0	2	3	4	0	0	4	0	2
Withdrew: Failure to meet continuation criteria	0	0	0	0	0	0	2	0	1
Withdrew: Lost to follow-up	0	0	1	3	0	0	1	0	0
Withdrew: Physician decision	0	1	0	0	0	0	0	0	0
Withdrew: Pregnancy	0	0	0	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	1	2	1	0	0	0	0	1

Outcome measures

PrimaryNumber 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)
Reported as:: Count of participants · Participants

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

PrimarySeverity 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)
Reported as:: Count of participants · Participants

Severity of TEAEs After a Single Dose of CD388
Participants	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	CD388 900 mg SQ	Pooled Placebo SQ
Mild	5	5	2	5	4	4	3	3	6
Moderate	0	0	3	2	1	0	1	0	1
Severe	0	0	0	1	0	0	1	0	0

SecondaryMean 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.

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)
Reported as:: Mean · micrograms/milliliter (ug/mL)

Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
micrograms/milliliter (ug/mL)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	4.13 ± 0.747	10.4 ± 2.44	48.6 ± 11.7	3.57 ± 0.942	12.0 ± 3.35	32.7 ± 9.40	58.8 ± 17.5

SecondaryMedian 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.

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)
Reported as:: Median · micrograms/milliliter (ug/mL)

Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
micrograms/milliliter (ug/mL)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	3.96 (2.91 to 5.34)	10.4 (6.52 to 13.6)	48.0 (35.2 to 67.7)	3.72 (2.17 to 4.83)	11.8 (6.84 to 17.0)	31.6 (16.6 to 48.0)	60.7 (34.3 to 91.3)

SecondaryMean 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.

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)
Reported as:: Mean · hours (h)

Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
hours (h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	111.08 ± 72.42	159.03 ± 83.10	85.64 ± 42.19	213.00 ± 108.43	137.48 ± 77.82	120.04 ± 67.83	109.54 ± 55.66

SecondaryMedian 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.

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)
Reported as:: Median · hours (h)

Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
hours (h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	96.07 (48.17 to 240.00)	131.98 (71.97 to 312.00)	78.31 (24.17 to 144.00)	228.00 (72.00 to 312.02)	131.28 (48.22 to 312.02)	96.00 (48.17 to 240.00)	96.00 (48.17 to 192.00)

SecondaryMean 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.

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)
Reported as:: Mean · hours (h)

Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388
hours (h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1234.41 ± 140.04	1192.03 ± 235.80	1006.20 ± 314.39	1069.78 ± 216.48	1265.53 ± 223.93	1065.21 ± 239.19	1384.36 ± 282.53

SecondaryMedianTerminal 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.

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)
Reported as:: Median · hours (h)

MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388
hours (h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1275.62 (985.09 to 1390.45)	1285.85 (783.24 to 1471.71)	1137.42 (540.88 to 1384.09)	1052.39 (685.81 to 1350.50)	1270.40 (796.65 to 1576.21)	1040.30 (809.64 to 1502.38)	1287.45 (1110.87 to 1998.04)

SecondaryMean 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)
Reported as:: Mean · liters/hour (L/h)

Mean Apparent Clearance (CL/F) Following a Single Administration of CD388
liters/hour (L/h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00751 ± 0.00119	0.00867 ± 0.00177	0.00766 ± 0.00199	0.00900 ± 0.00230	0.00725 ± 0.00123	0.00883 ± 0.00213	0.00863 ± 0.00158

SecondaryMedian 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)
Reported as:: Median · liters/hour (L/h)

Median Apparent Clearance (CL/F) Following a Single Administration of CD388
liters/hour (L/h)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00707 (0.00614 to 0.00991)	0.00851 (0.00640 to 0.0112)	0.00726 (0.00571 to 0.0116)	0.00834 (0.00591 to 0.0128)	0.00717 (0.00551 to 0.00909)	0.00912 (0.00493 to 0.0115)	0.00870 (0.00648 to 0.0111)

SecondaryMean 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.

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)
Reported as:: Mean · liters (L)

Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
liters (L)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.3 ± 1.91	14.8 ± 4.40	10.7 ± 2.99	13.4 ± 2.59	13.3 ± 3.70	13.1 ± 2.61	17.1 ± 3.76

SecondaryMedian 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.

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)
Reported as:: Median · liters (L)

Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
liters (L)	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.9 (10.3 to 15.8)	14.4 (11.1 to 23.9)	10.9 (6.47 to 15.1)	12.2 (11.4 to 18.7)	12.7 (9.27 to 20.7)	12.9 (10.7 to 18.9)	16.7 (11.2 to 24.2)

SecondaryMean 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.

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)
Reported as:: Mean · ug*h/mL

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
ug*h/mL	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 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	5450 ± 728	15000 ± 4320	53800 ± 12000	4830 ± 965	18800 ± 3360	49000 ± 13100	96300 ± 16700

SecondaryMedian 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

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)
Reported as:: Median · ug*h/mL

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
ug*h/mL	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 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	5460 (4410 to 6530)	15100 (7250 to 21100)	52100 (37600 to 71200)	4960 (3270 to 6300)	18700 (13700 to 24400)	46500 (34800 to 76600)	94700 (71700 to 121000)

SecondaryMean 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.

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)
Reported as:: Mean · ug*h/mL

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
ug*h/mL	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	6790 ± 973	17900 ± 3670	61800 ± 13600	5870 ± 1470	21200 ± 3670	54400 ± 16900	107000 ± 19700

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

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)
Reported as:: Median · ug*h/mL

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
ug*h/mL	Cohort 1A CD388 50 mg IM	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 1B CD388 50 mg SQ	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ	Cohort 4B CD388 900 mg SQ
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388	7080 (5050 to 8140)	17600 (13300 to 23400)	62100 (38800 to 78800)	6000 (3920 to 8470)	21000 (16500 to 27200)	49300 (39100 to 91400)	103000 (80800 to 139000)

SecondaryMean 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)
Reported as:: Mean · micrograms/milliliter (ug/mL)

Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
micrograms/milliliter (ug/mL)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	10.5 ± 3.30	28.8 ± 7.66	13.0 ± 5.34	31.1 ± 7.86

SecondaryMedian 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)
Reported as:: Median · micrograms/milliliter (ug/mL)

Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
micrograms/milliliter (ug/mL)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388	9.94 (6.68 to 14.4)	29.8 (18.0 to 38.3)	12.5 (6.84 to 22.0)	29.3 (23.8 to 43.8)

SecondaryMean 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)
Reported as:: Mean · hours (h)

Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
hours (h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	104.02 ± 81.25	161.14 ± 75.53	251.99 ± 200.79	105.02 ± 49.89

SecondaryMedian 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)
Reported as:: Median · hours (h)

Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
hours (h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388	84.00 (48.00 to 264.00)	144.00 (48.00 to 264.00)	227.99 (48.00 to 695.97)	96.00 (47.07 to 167.00)

SecondaryMean 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)
Reported as:: Mean · hours (h)

Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
hours (h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1324.07 ± 198.33	1408.43 ± 336.72	1059.55 ± 409.51	1301.42 ± 83.00

SecondaryMedian 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)
Reported as:: Median · hours (h)

Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
hours (h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388	1342.81 (1108.91 to 1639.43)	1506.38 (670.64 to 1721.28)	1218.60 (508.57 to 1539.09)	1348.40 (1175.81 to 1371.62)

SecondaryMean 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)
Reported as:: Mean · liters/hour (L/h)

Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
liters/hour (L/h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00923 ± 0.00123	0.00886 ± 0.00170	0.00802 ± 0.00218	0.00897 ± 0.00210

SecondaryMedian 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)
Reported as:: Median · liters/hour (L/h)

Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
liters/hour (L/h)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388	0.00954 (0.00706 to 0.0104)	0.00918 (0.00642 to 0.0105)	0.00866 (0.00507 to 0.0116)	0.00946 (0.00534 to 0.0106)

SecondaryMean 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)
Reported as:: Mean · liters (L)

Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
liters (L)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	17.4 ± 1.85	17.8 ± 5.45	11.7 ± 4.70	16.7 ± 3.55

SecondaryMedian 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)
Reported as:: Median · liters (L)

Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
liters (L)	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388	16.6 (15.4 to 20.2)	16.7 (10.1 to 26.0)	9.46 (7.45 to 19.2)	18.3 (10.4 to 18.5)

SecondaryMean 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)
Reported as:: Mean · ug*h/mL

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
ug*h/mL	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B 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 Repeated Single Administration of CD388	14400 ± 2050	41300 ± 15400	18000 ± 5090	41100 ± 21100

SecondaryMedian 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)
Reported as:: Median · ug*h/mL

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
ug*h/mL	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B 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 Repeated Single Administration of CD388	13600 (12800 to 18000)	41800 (13400 to 60600)	16000 (12900 to 26600)	39100 (13400 to 72700)

SecondaryMean 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)
Reported as:: Mean · ug*h/mL

Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
ug*h/mL	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	16500 ± 2530	52600 ± 10800	20000 ± 5830	53400 ± 17400

SecondaryMedian 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)
Reported as:: Median · ug*h/mL

Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
ug*h/mL	Cohort 2A CD388 150 mg IM	Cohort 3A CD388 450 mg IM	Cohort 2B CD388 150 mg SQ	Cohort 3B CD388 450 mg SQ
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388	15700 (14500 to 21200)	49000 (42900 to 70100)	17300 (12900 to 29600)	47600 (42300 to 84300)

SecondaryNumber 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)
Reported as:: Count of participants · Participants

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

SecondarySeverity 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)
Reported as:: Count of participants · Participants

Severity of TEAEs After a Repeated Single Dose of CD388
Participants	CD388 150 mg IM	CD388 450 mg IM	Pooled Placebo IM	CD388 150 mg SQ	CD388 450 mg SQ	Pooled Placebo SQ
Mild	2	2	2	2	3	1
Moderate	0	2	0	0	0	0
Severe	0	0	0	0	0	0

Adverse events

Collected over Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm [Cohorts 1A/1B]; Day 412 for the 150 mg and 450 mg dose arms [Cohorts 2A/2B and 3A/3B]; and Day 206 for the 900 mg dose arm [Cohort 4B]).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CD388 50 mg IM	0/8 (0%)	0/8 (0%)	5/8 (62.5%)
CD388 150 mg IM	0/8 (0%)	0/8 (0%)	5/8 (62.5%)
CD388 450 mg IM	0/8 (0%)	0/8 (0%)	6/8 (75%)
Pooled Placebo IM	0/9 (0%)	0/9 (0%)	8/9 (88.9%)
CD388 50 mg SQ	0/8 (0%)	0/8 (0%)	5/8 (62.5%)
CD388 150 mg SQ	0/8 (0%)	0/8 (0%)	4/8 (50%)
CD388 450 mg SQ	0/8 (0%)	0/8 (0%)	6/8 (75%)
CD388 900 mg SQ	0/8 (0%)	0/8 (0%)	3/8 (37.5%)
Pooled Placebo SQ	0/12 (0%)	0/12 (0%)	7/12 (58.3%)

Most frequent other events

Showing 10 of 65

Most frequent other events
Event	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	CD388 900 mg SQ	Pooled Placebo SQ
HeadacheNervous system disorders	0/8	2/8	2/8	4/9	5/8	0/8	2/8	0/8	2/12
Viral infectionInfections and infestations	0/8	1/8	3/8	1/9	0/8	0/8	0/8	0/8	1/12
COVID-19Infections and infestations	1/8	2/8	1/8	2/9	0/8	1/8	0/8	0/8	0/12
PresyncopeNervous system disorders	0/8	0/8	0/8	0/9	0/8	2/8	0/8	0/8	1/12
Injection site painGeneral disorders	0/8	0/8	1/8	2/9	0/8	0/8	0/8	0/8	1/12
Back painMusculoskeletal and connective tissue disorders	0/8	0/8	0/8	2/9	0/8	1/8	1/8	0/8	0/12
CoughRespiratory, thoracic and mediastinal disorders	0/8	1/8	0/8	2/9	0/8	0/8	0/8	0/8	0/12
DizzinessNervous system disorders	0/8	0/8	0/8	1/9	0/8	0/8	0/8	0/8	2/12
NauseaGastrointestinal disorders	0/8	1/8	1/8	1/9	0/8	0/8	0/8	0/8	1/12
VomitingGastrointestinal disorders	0/8	0/8	0/8	0/9	1/8	0/8	0/8	0/8	1/12

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Mean	38.9 ± 7.77	41.1 ± 12.83	38.6 ± 12.73	39.0 ± 15.51	42.8 ± 12.58	32.8 ± 10.75	39.3 ± 14.95	41.9 ± 13.97	39.4 ± 13.82	39.3 ± 12.62

Age, Continuous
Age, Continuous(years)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Median	37.0 (30 to 55)	38.5 (24 to 57)	32.5 (28 to 63)	30.0 (23 to 65)	45.5 (21 to 56)	30.5 (22 to 50)	35.5 (19 to 62)	34.0 (29 to 65)	37.5 (18 to 59)	35.0 (18 to 65)

Sex: Female, Male
Sex: Female, Male(Participants)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Female	1	4	1	5	3	1	2	1	5	23
Male	7	4	7	4	5	7	6	7	7	54

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Hispanic or Latino	0	3	1	0	0	1	1	0	0	6
Not Hispanic or Latino	8	5	7	9	8	7	7	8	12	71
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0
Asian	0	0	1	1	0	0	0	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0
Black or African American	3	3	3	4	4	6	5	7	8	43
White	5	4	4	3	4	2	3	1	4	30
More than one race	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	1	0	1	0	0	0	0	0	2

Weight
Weight(kilograms (kg))	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Mean	86.19 ± 5.680	79.53 ± 11.945	79.51 ± 16.157	79.97 ± 12.596	83.15 ± 19.835	81.03 ± 17.053	85.28 ± 16.085	86.30 ± 10.079	76.73 ± 13.775	81.67 ± 13.847

Weight
Weight(kg)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Median	85.50 (77.6 to 95.3)	80.40 (64.8 to 99.9)	75.60 (63.0 to 105.9)	80.90 (55.0 to 95.2)	78.75 (59.9 to 112.5)	78.20 (59.5 to 115.8)	83.75 (64.1 to 118.6)	87.90 (68.5 to 99.9)	79.50 (55.4 to 101.7)	81.70 (55.0 to 118.6)

Height
Height(centimeters)	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	CD388 900 mg SQ	Pooled Placebo SQ	Total
Mean	178.88 ± 8.919	172.25 ± 11.498	174.50 ± 6.655	172.00 ± 10.283	173.38 ± 11.975	172.38 ± 10.993	172.00 ± 11.514	176.19 ± 7.348	171.17 ± 7.884	173.49 ± 9.529

3 further baseline measures are reported on the registry.

Study locations

1 site

Altasciences Clinical Kansas, Inc.
Overland Park, Kansas 66212, United States

References and documents

Study documents

Study protocol · Feb 7, 2023
Statistical analysis plan · Dec 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05285137
Lead sponsor: Cidara Therapeutics Inc.
Collaborators: Janssen Pharmaceuticals
Responsible party: Sponsor
First posted: Mar 17, 2022
Start date: Mar 14, 2022
Primary completion: Oct 27, 2023
Completion: Oct 27, 2023
Results posted: Jan 24, 2025
Last update: Feb 27, 2025

Study contacts

Ozlem Equils, MD

study director · Cidara Therapeutics Inc.

Debra J Kelsh, MD

principal investigator · Altasciences Clinical Kansas, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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