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Monoclonal Antibodies

Cohort 2 for Healthy 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)

Awards & highlights

Study Summary

This trial tests if CD388 Injection is safe and tolerated when given as a single dose in healthy Japanese adults.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after a Single Dose of CD388

Secondary outcome measures

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

~22170

CD388 Injection

2022

Completed Phase 1

~110

Do I qualify?Apply below to find out

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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

80 Previous Clinical Trials

205,043 Total Patients Enrolled

Cidara Therapeutics Inc.Lead Sponsor

10 Previous Clinical Trials

2,219 Total Patients Enrolled

Youngjun Kim, MDPrincipal InvestigatorAltasciences Clinical Los Angeles, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications to participate in this research?

"This study demands 18 participants, aged between the ages of eighteen and sixty-five with healthy subjective states (hs). Additionally, they must be Japanese descending on both their maternal and paternal sides as reported by themselves. Willingness to provide written consent is also a necessity for those looking to join this clinical trial. Furthermore, male or female volunteers have to fulfill various requirements such as using contraception if capable of bearing children; being surgically sterile or past menopause in case incapable; having negative serum/urine pregnancy tests at screening & day -1 before first dose respectively; abstaining from donating eggs during the course & at least 7 months"

Answered by AI

What is the size of the cohort involved in this research?

"Affirmative, the information accessible on clinicaltrials.gov indicates that this medical experiment is actively enrolling volunteers. First posted on October 18th 2022 and updated as recently as November 9th 2022, the trial seeks to recruit a total of eighteen patients from one site."

Answered by AI

To what degree can Cohort 1 be potentially hazardous to those involved?

"Cohort 1's safety score was assessed at a value of one due to the limited research data available concerning its efficacy and security."

Answered by AI

Does this clinical trial accept applicants who are over 50 years of age?

"As per the requirements of this clinical trial, only those aged 18 or above and 65 or under are welcome to participate."

Answered by AI

Are there any vacancies for participants in this research endeavor?

"Affirmative. The public data found on clinicaltrials.gov confirms that this investigation, which was initially published on October 18th 2022, is actively recruiting participants. They are aiming to find 18 volunteers from one medical site in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

2022. "Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05619536.