NCT05619536

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when dosed by subcutaneous (SQ) administration as a single dose to healthy Japanese adult subjects.

Detailed description

This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals are to assess safety, tolerability, and pharmacokinetics (PK) of CD388.

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: 2022-10-18
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2022-11-17
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study