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

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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: CD101 IV Drug: Placebo Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CD101 IV
multiple ascending dose intravenous infusion
 Drug: CD101 IV
antifungal
Placebo Comparator: Placebo
normal saline
 Drug: Placebo
Normal saline


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551549


Locations
Layout table for location information
United States, Arizona
Celerion Inc
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
Layout table for investigator information
Principal Investigator: Danielle Armas, MD Celerion
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02551549    
Other Study ID Numbers: CD101.IV.1.02
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cidara Therapeutics Inc.:
Subjects
Additional relevant MeSH terms:
Layout table for MeSH terms
Rezafungin
Antifungal Agents
Anti-Infective Agents