Expired Study
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Tempe, Arizona 85283


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT02551549


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: January 21, 2020

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