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An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

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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
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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
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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
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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
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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
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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
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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
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United States, Arizona
Celerion Inc
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
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Principal Investigator: Danielle Armas, MD Celerion
More Information
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Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02551549     History of Changes
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:
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Rezafungin
Antifungal Agents
Anti-Infective Agents