Trial Outcomes & Findings for Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects (NCT NCT05285137)

Last Updated: 2025-02-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

77 participants

Primary outcome timeframe

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)

Results posted on

2025-02-27

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 milestones

Participant milestones
Measure	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	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	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	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	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	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	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	CD388 900 mg SQ Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	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
Overall Study STARTED	8	8	8	9	8	8	8	8	12
Overall Study COMPLETED	8	6	5	5	8	8	4	8	10
Overall Study NOT COMPLETED	0	2	3	4	0	0	4	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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	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
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

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD388 50 mg IM n=8 Participants Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants 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	CD388 450 mg IM n=8 Participants 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	Pooled Placebo IM n=9 Participants 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	CD388 50 mg SQ n=8 Participants Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants 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	CD388 450 mg SQ n=8 Participants 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	CD388 900 mg SQ n=8 Participants Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ n=12 Participants 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	Total n=77 Participants Total of all reporting groups
Age, Continuous	37.0 years n=5 Participants	38.5 years n=7 Participants	32.5 years n=5 Participants	30.0 years n=4 Participants	45.5 years n=21 Participants	30.5 years n=8 Participants	35.5 years n=8 Participants	34.0 years n=24 Participants	37.5 years n=42 Participants	35.0 years n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants	23 Participants n=42 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	6 Participants n=8 Participants	7 Participants n=24 Participants	7 Participants n=42 Participants	54 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	7 Participants n=8 Participants	8 Participants n=24 Participants	12 Participants n=42 Participants	71 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	5 Participants n=8 Participants	7 Participants n=24 Participants	8 Participants n=42 Participants	43 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants	30 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Weight	85.50 kg n=5 Participants	80.40 kg n=7 Participants	75.60 kg n=5 Participants	80.90 kg n=4 Participants	78.75 kg n=21 Participants	78.20 kg n=8 Participants	83.75 kg n=8 Participants	87.90 kg n=24 Participants	79.50 kg n=42 Participants	81.70 kg n=42 Participants
Height	179.00 centimeters n=5 Participants	173.50 centimeters n=7 Participants	176.00 centimeters n=5 Participants	177.00 centimeters n=4 Participants	176.50 centimeters n=21 Participants	174.00 centimeters n=8 Participants	169.50 centimeters n=8 Participants	176.75 centimeters n=24 Participants	171.50 centimeters n=42 Participants	175.00 centimeters n=42 Participants
Body Mass Index	27.95 kg/m^2 n=5 Participants	26.95 kg/m^2 n=7 Participants	25.20 kg/m^2 n=5 Participants	28.70 kg/m^2 n=4 Participants	27.30 kg/m^2 n=21 Participants	27.00 kg/m^2 n=8 Participants	29.35 kg/m^2 n=8 Participants	26.80 kg/m^2 n=24 Participants	26.05 kg/m^2 n=42 Participants	27.00 kg/m^2 n=42 Participants

PRIMARY outcome

Timeframe: 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 \[SQ route\]).

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=9 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ n=8 Participants Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ n=12 Participants Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388 Participants with at least one TEAE	5 Participants	5 Participants	5 Participants	8 Participants	5 Participants	4 Participants	5 Participants	3 Participants	7 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388 Participants with AEs leading to study withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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 \[SQ route\]).

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.

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=9 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ n=8 Participants Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ n=12 Participants Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Severity of TEAEs After a Single Dose of CD388 Mild	5 Participants	5 Participants	2 Participants	5 Participants	4 Participants	4 Participants	3 Participants	3 Participants	6 Participants
Severity of TEAEs After a Single Dose of CD388 Moderate	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Severity of TEAEs After a Single Dose of CD388 Severe	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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 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.

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	4.13 micrograms/milliliter (ug/mL) Standard Deviation 0.747	10.4 micrograms/milliliter (ug/mL) Standard Deviation 2.44	48.6 micrograms/milliliter (ug/mL) Standard Deviation 11.7	3.57 micrograms/milliliter (ug/mL) Standard Deviation 0.942	12.0 micrograms/milliliter (ug/mL) Standard Deviation 3.35	32.7 micrograms/milliliter (ug/mL) Standard Deviation 9.40	58.8 micrograms/milliliter (ug/mL) Standard Deviation 17.5	—	—

SECONDARY outcome

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.

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388	3.96 micrograms/milliliter (ug/mL) Interval 2.91 to 5.34	10.4 micrograms/milliliter (ug/mL) Interval 6.52 to 13.6	48.0 micrograms/milliliter (ug/mL) Interval 35.2 to 67.7	3.72 micrograms/milliliter (ug/mL) Interval 2.17 to 4.83	11.8 micrograms/milliliter (ug/mL) Interval 6.84 to 17.0	31.6 micrograms/milliliter (ug/mL) Interval 16.6 to 48.0	60.7 micrograms/milliliter (ug/mL) Interval 34.3 to 91.3	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	111.08 hours (h) Standard Deviation 72.42	159.03 hours (h) Standard Deviation 83.10	85.64 hours (h) Standard Deviation 42.19	213.00 hours (h) Standard Deviation 108.43	137.48 hours (h) Standard Deviation 77.82	120.04 hours (h) Standard Deviation 67.83	109.54 hours (h) Standard Deviation 55.66	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388	96.07 hours (h) Interval 48.17 to 240.0	131.98 hours (h) Interval 71.97 to 312.0	78.31 hours (h) Interval 24.17 to 144.0	228.00 hours (h) Interval 72.0 to 312.02	131.28 hours (h) Interval 48.22 to 312.02	96.00 hours (h) Interval 48.17 to 240.0	96.00 hours (h) Interval 48.17 to 192.0	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388	1234.41 hours (h) Standard Deviation 140.04	1192.03 hours (h) Standard Deviation 235.80	1006.20 hours (h) Standard Deviation 314.39	1069.78 hours (h) Standard Deviation 216.48	1265.53 hours (h) Standard Deviation 223.93	1065.21 hours (h) Standard Deviation 239.19	1384.36 hours (h) Standard Deviation 282.53	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388	1275.62 hours (h) Interval 985.09 to 1390.45	1285.85 hours (h) Interval 783.24 to 1471.71	1137.42 hours (h) Interval 540.88 to 1384.09	1052.39 hours (h) Interval 685.81 to 1350.5	1270.40 hours (h) Interval 796.65 to 1576.21	1040.30 hours (h) Interval 809.64 to 1502.38	1287.45 hours (h) Interval 1110.87 to 1998.04	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00751 liters/hour (L/h) Standard Deviation 0.00119	0.00867 liters/hour (L/h) Standard Deviation 0.00177	0.00766 liters/hour (L/h) Standard Deviation 0.00199	0.00900 liters/hour (L/h) Standard Deviation 0.00230	0.00725 liters/hour (L/h) Standard Deviation 0.00123	0.00883 liters/hour (L/h) Standard Deviation 0.00213	0.00863 liters/hour (L/h) Standard Deviation 0.00158	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Median Apparent Clearance (CL/F) Following a Single Administration of CD388	0.00707 liters/hour (L/h) Interval 0.00614 to 0.00991	0.00851 liters/hour (L/h) Interval 0.0064 to 0.0112	0.00726 liters/hour (L/h) Interval 0.00571 to 0.0116	0.00834 liters/hour (L/h) Interval 0.00591 to 0.0128	0.00717 liters/hour (L/h) Interval 0.00551 to 0.00909	0.00912 liters/hour (L/h) Interval 0.00493 to 0.0115	0.00870 liters/hour (L/h) Interval 0.00648 to 0.0111	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.3 liters (L) Standard Deviation 1.91	14.8 liters (L) Standard Deviation 4.40	10.7 liters (L) Standard Deviation 2.99	13.4 liters (L) Standard Deviation 2.59	13.3 liters (L) Standard Deviation 3.70	13.1 liters (L) Standard Deviation 2.61	17.1 liters (L) Standard Deviation 3.76	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388	13.9 liters (L) Interval 10.3 to 15.8	14.4 liters (L) Interval 11.1 to 23.9	10.9 liters (L) Interval 6.47 to 15.1	12.2 liters (L) Interval 11.4 to 18.7	12.7 liters (L) Interval 9.27 to 20.7	12.9 liters (L) Interval 10.7 to 18.9	16.7 liters (L) Interval 11.2 to 24.2	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
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	15000 ug*h/mL Standard Deviation 4320	53800 ug*h/mL Standard Deviation 12000	4830 ug*h/mL Standard Deviation 965	18800 ug*h/mL Standard Deviation 3360	49000 ug*h/mL Standard Deviation 13100	96300 ug*h/mL Standard Deviation 16700	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=8 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
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 Interval 4410.0 to 6530.0	15100 ug*h/mL Interval 7250.0 to 21100.0	52100 ug*h/mL Interval 37600.0 to 71200.0	4960 ug*h/mL Interval 3270.0 to 6300.0	18700 ug*h/mL Interval 13700.0 to 24400.0	46500 ug*h/mL Interval 34800.0 to 76600.0	94700 ug*h/mL Interval 71700.0 to 121000.0	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	CD388 50 mg IM n=8 Participants Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection. CD388: CD388 liquid for injection	CD388 150 mg IM n=7 Participants Participants randomized to Cohort 2A 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	CD388 450 mg IM n=8 Participants Participants randomized to Cohort 3A 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	Pooled Placebo IM n=8 Participants Participants randomized to Cohort 1A, 2A, or 3A 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 (Cohort 2A) and CD388 450 mg IM (Cohort 3A) 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	CD388 50 mg SQ n=8 Participants Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection. CD388: CD388 liquid for injection	CD388 150 mg SQ n=8 Participants Participants randomized to Cohort 2B 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	CD388 450 mg SQ n=8 Participants Participants randomized to Cohort 3B 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	CD388 900 mg SQ Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection. CD388: CD388 liquid for injection	Pooled Placebo SQ Participants randomized to Cohort 1B, 2B, 3B, or 4B 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 (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) 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
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	17900 ug*h/mL Standard Deviation 3670	61800 ug*h/mL Standard Deviation 13600	5870 ug*h/mL Standard Deviation 1470	21200 ug*h/mL Standard Deviation 3670	54400 ug*h/mL Standard Deviation 16900	107000 ug*h/mL Standard Deviation 19700	—	—