An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

CD101 IVDRUG

antifungal

PlaceboDRUG

Normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men must be surgically sterilized or using contraception, * No significant findings on physical exam, ECG, clinical laboratory tests, * Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive * Must provide written informed consent Exclusion Criteria: * Females of child bearing potential * Signs and or symptoms of acute illness or chronic disease * Use of prescription medications within 28 days * Use of OTC, supplements, and herbals within 14 days * Current smoker * Previous participation in a clinical study within 28 days

Locations (1)

Celerion Inc

Tempe, Arizona, United States