A Single Ascending Dose Study of CD101 IV in Healthy Subjects

May 20, 2024 updated by: Cidara Therapeutics Inc.

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

A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males surgically sterilized or using contraception,
  • No significant findings on physical, ECG, clinical laboratory tests,
  • BMI between 18.5 - 32.0,
  • Must provide informed consent

Exclusion Criteria:

  • Females of child bearing potential,
  • Signs and or symptoms of an acute or chronic illness,
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
normal saline
Drug: Placebo
normal saline
Experimental: CD101 IV
single intravenous infusion ascending dose
Drug: CD101 IV
antifungal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with clinically significant adverse events (AEs)
Time Frame: Up to 3 weeks
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)
Time Frame: Up to 3 weeks
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cidara Therapeutics Inc.

Investigators

  • Principal Investigator: Danielle Armas, MD, Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimated)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD101.IV.1.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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