A Single Ascending Dose Study of CD101 IV in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CD101 IV

single intravenous infusion ascending dose

Group Type EXPERIMENTAL

CD101 IV

Intervention Type DRUG

antifungal

Placebo

normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline

Interventions

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CD101 IV

antifungal

Intervention Type DRUG

Placebo

normal saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes