An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CD101 IV; Drug: Placebo

• Registration Number: NCT02551549
• Lead Sponsor: Cidara Therapeutics Inc.

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD101 IV	CD101 IV	multiple ascending dose intravenous infusion
Placebo	Placebo	normal saline

Primary Outcome Measures

Name	Time	Method
Safety as assessed by the number of subjects with clinically significant adverse events	Up to 2 weeks following last dose of study drug	Number of subjects with clinically significant adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax)	Up to 2 weeks following last dose of study drug
Time to reach peak plasma concentration (Tmax)	Up to 2 weeks following last dose of study drug
Area under the concentration time curve (AUC)	Up to 2 weeks following last dose of study drug
Terminal half-life (t1/2)	Up to 2 weeks following last dose of study drug
The volume of plasma cleared of the drug per unit time (CL)	Up to 2 weeks following last dose of study drug
Apparent volume in which the drug is distributed (Vz)	Up to 2 weeks following last dose of study drug
The rate at which a drug is removed from the body (^z),	Up to 2 weeks following last dose of study drug

Trial Locations

Locations (1)

Celerion Inc; 🇺🇸 Tempe, Arizona, United States