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Completed

NCT Number: NCT02551549

An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion Inc

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD101 IV

Drug

antifungal

Placebo

Drug

Normal saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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