Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551549
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Cidara Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 16, 2015
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02551549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • Peak plasma concentration (Cmax) [ Time Frame: 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 ]
  • Area under the concentration time curve (AUC) [ Time Frame: 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 ]
  • Apparent volume in which the drug is distributed (Vz) [ Time Frame: 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 ]
  • Terminal half-life (t1/2) [ Time Frame: Up to 2 weeks following last dose of study drug ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CD101 IV
    antifungal
  • Drug: Placebo
    Normal saline
Study Arms  ICMJE
  • Experimental: CD101 IV
    multiple ascending dose intravenous infusion
    Intervention: Drug: CD101 IV
  • Placebo Comparator: Placebo
    normal saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02551549
Other Study ID Numbers  ICMJE CD101.IV.1.02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cidara Therapeutics Inc.
Study Sponsor  ICMJE Cidara Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Danielle Armas, MD Celerion
PRS Account Cidara Therapeutics Inc.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP