NCT02551549

An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

Detailed description

This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CD101 IV	antifungal
DRUG	Placebo	Normal saline

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-09-16
• Last updated: 2017-06-26

Locations

1 site across 1 country: United States