Trial | NCT02516904  Report issue

Title

A Single Ascending Dose Study of CD101 IV in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cd101 ...

  • Study Participants

    32
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
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.
Study Started
Jul 31
2015
Primary Completion
Oct 31
2015
Study Completion
Oct 31
2015
Last Update
Jun 26
2017

Drug CD101 IV

antifungal

Drug Placebo

normal saline

CD101 IV Experimental

single intravenous infusion ascending dose

Placebo Placebo Comparator

normal saline

Criteria 

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
No Results Posted