Expired Study
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Tempe, Arizona 85283


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT02516904


Primary Contact:

Principal Investigator
Danielle Armas, MD
Celerion


Backup Contact:

N/A


Location Contact:

Tempe, Arizona 85283
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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