NCT05285137

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat single-dose, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CD388 Injection	CD388 liquid for injection
DRUG	Saline placebo	Sterile normal saline for injection

Timeline

• Start date: 2022-03-14
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2022-03-17
• Last updated: 2025-02-27
• Results posted: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study