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CD388 Injection for Healthy Subjects

Phase 1
Waitlist Available
Led By Debra J Kelsh, 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 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, 168, 251, 290, 332, and 374 (cohorts 2a/2b and 3a/3b); or days 45, 84, 126, 168, and 206 (cohort 4b only)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerable for humans. The drug will be injected into muscle or under skin, and compared to a saline placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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, 168, 251, 290, 332, and 374 (cohorts 2a/2b and 3a/3b); or days 45, 84, 126, 168, and 206 (cohort 4b only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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, 168, 251, 290, 332, and 374 (cohorts 2a/2b and 3a/3b); or days 45, 84, 126, 168, and 206 (cohort 4b 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
+5 more

Trial Design

14Treatment groups
Experimental Treatment
Group I: Cohort 4B (sentinel)Experimental Treatment2 Interventions
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
Group II: Cohort 4B (main)Experimental Treatment2 Interventions
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
Group III: Cohort 3B (sentinel)Experimental Treatment2 Interventions
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
Group IV: Cohort 3B (main)Experimental Treatment2 Interventions
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
Group V: Cohort 3A (sentinel)Experimental Treatment2 Interventions
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
Group VI: Cohort 3A (main)Experimental Treatment2 Interventions
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
Group VII: Cohort 2B (sentinel)Experimental Treatment2 Interventions
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
Group VIII: Cohort 2B (main)Experimental Treatment2 Interventions
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
Group IX: Cohort 2A (sentinel)Experimental Treatment2 Interventions
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
Group X: Cohort 2A (main)Experimental Treatment2 Interventions
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
Group XI: Cohort 1B (sentinel)Experimental Treatment2 Interventions
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
Group XII: Cohort 1B (main)Experimental Treatment2 Interventions
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
Group XIII: Cohort 1A (sentinel)Experimental Treatment2 Interventions
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
Group XIV: Cohort 1A (main)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CD388 Injection
2022
Completed Phase 1
~110
Saline placebo
2005
Completed Phase 4
~22170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cidara Therapeutics Inc.Lead Sponsor
10 Previous Clinical Trials
2,169 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
204,993 Total Patients Enrolled
Ozlem Equils, MDStudy DirectorCidara Therapeutics Inc.
2 Previous Clinical Trials
87 Total Patients Enrolled

Media Library

CD388 Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05285137 — Phase 1
Healthy Subjects Research Study Groups: Cohort 3A (main), Cohort 2A (main), Cohort 2B (main), Cohort 4B (main), Cohort 2B (sentinel), Cohort 3A (sentinel), Cohort 1A (main), Cohort 1B (sentinel), Cohort 1B (main), Cohort 2A (sentinel), Cohort 3B (sentinel), Cohort 3B (main), Cohort 4B (sentinel), Cohort 1A (sentinel)
Healthy Subjects Clinical Trial 2023: CD388 Injection Highlights & Side Effects. Trial Name: NCT05285137 — Phase 1
CD388 Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285137 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05285137 — Phase 1

Frequently Asked Questions

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

Is this clinical trial testing a new drug on patients who are over 20 years old?

"According to the medical trial's eligibility requirements, patients must be aged 18-65. Out of the 442 total clinical trials, 52 are for individuals under 18 and 390 are for those over 65."

Answered by AI

I am interested in helping to test this new medication, how can I sign up?

"This study is admitting 66 people with healthy subjects (hs) aged 18 and 65. Most importantly, patients should meet the following criteria: Willing and able to provide written informed consent., Males and females 18 to 65 years of age, inclusive., 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 3 months or 5 effective half-lives after last dose of study medication, whichever is longer. Examples of"

Answered by AI

Is there a low risk for negative side effects from CD388 Injection?

"CD388 Injection's safety is based on early data from Phase 1 trials, meaning that its efficacy and safety have only been supported by limited data. We've given it a score of 1."

Answered by AI

To date, how many individuals have enrolled in this experiment?

"The clinical trial is currently looking for 66 patients from 1 site, as indicated by the most recent update on clinicaltrials.gov from 6/24/2022. The trial was first posted on 3/14/2022."

Answered by AI

Is there still room for people in this clinical trial?

"Information available on clinicaltrials.gov verifies that this trial is actively seeking patients. The trial was first announced on March 14th, 2022 and was most recently updated on June 24th, 2022. The study is looking for 66 patients at a single location."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
Kansas
Florida
What site did they apply to?
Altasciences Clinical Kansas, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for paid studies.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
2022. "Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05285137.
~25 spots leftby Apr 2025
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