An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

June 22, 2017 updated by: Cidara Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

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

No

Genders Eligible for Study

All

Description

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 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
multiple ascending dose intravenous infusion
Drug: CD101 IV
antifungal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as assessed by the number of subjects with clinically significant adverse events
Time Frame: Up to 2 weeks following last dose of study drug
Number of subjects with clinically significant adverse events (AEs)
Up to 2 weeks following last dose of study drug

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Cidara Therapeutics Inc.

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

September 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD101.IV.1.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe