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Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

NCT05285137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-02-27

Study results available
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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.

Conditions

  • Healthy

Interventions

COMBINATION_PRODUCT

CD388 Injection

CD388 liquid for injection

DRUG

Saline placebo

Sterile normal saline for injection

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Cidara Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Ozlem Equils, MD · Cidara Therapeutics Inc.

  • Debra J Kelsh, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2023-10-27
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285137 on ClinicalTrials.gov