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Monoclonal Antibodies

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

Phase 1
Waitlist Available
Led By Youngjun Kim, MD
Research Sponsored by Cidara Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at inpatient visits on days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on day 30 (±3 days), day 45 (±3 days), day 60 (±5 days), day 90 (±7 days), and either day 120 (±14 days) (cohort 1 only) or day 165 (±14 days) (cohorts 2 and 3 only)

Summary

This trial is testing the safety and tolerability of a new injection called CD388 in healthy Japanese adults. The injection is given under the skin, and researchers want to see how the body handles it and if it is safe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at inpatient visits on days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on day 30 (±3 days), day 45 (±3 days), day 60 (±5 days), day 90 (±7 days), and either day 120 (±14 days) (cohort 1 only) or day 165 (±14 days) (cohorts 2 and 3 only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at inpatient visits on days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on day 30 (±3 days), day 45 (±3 days), day 60 (±5 days), day 90 (±7 days), and either day 120 (±14 days) (cohort 1 only) or day 165 (±14 days) (cohorts 2 and 3 only) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Secondary study objectives
Apparent Clearance (CL/F) Following CD388 Injection Administration
Apparent Volume of Distribution (VZ/F) Following CD388 Injection Administration
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following CD388 Injection Administration
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
9 subjects randomized in a 7:2 ratio to receive either 450 mg CD388 SQ injection or matching placebo injection
Group II: Cohort 2Experimental Treatment2 Interventions
9 subjects randomized in a 7:2 ratio to receive either 150 mg CD388 SQ injection or matching placebo injection
Group III: Cohort 1Experimental Treatment2 Interventions
9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline placebo
2005
Completed Phase 4
~22080
CD388 Injection
2022
Completed Phase 1
~110

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
83 Previous Clinical Trials
205,217 Total Patients Enrolled
Cidara Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
7,357 Total Patients Enrolled
Youngjun Kim, MDPrincipal InvestigatorAltasciences Clinical Los Angeles, Inc.
Ozlem Equils, MDStudy DirectorCidara Therapeutics Inc.
2 Previous Clinical Trials
137 Total Patients Enrolled
~9 spots leftby Dec 2025
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