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NCT Number: NCT02516904

A Single Ascending Dose Study of CD101 IV in Healthy Subjects

A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

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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 ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males surgically sterilized or using contraception,
  • No significant findings on physical, ECG, clinical laboratory tests,
  • BMI between 18.5 - 32.0,
  • Must provide informed consent

Exclusion criteria

  • Females of child bearing potential,
  • Signs and or symptoms of an acute or chronic illness,
  • 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. Number of subjects with clinically significant adverse events (AEs)

    Time frame: Up to 3 weeks

Secondary outcomes

  1. Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)

    Time frame: Up to 3 weeks

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, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2015
Registry last updated
May 22, 2024

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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