A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cP12 in Health Adults
Abstract
The overall objective of this proposal is to assess the safety and tolerability of single ascending intravenous doses of cP12 in healthy subjects. This is a randomized double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, and pharmacokinetic profile of cP12 in healthy male and female subjects. Each subject is randomized to receive either a single dose of cP12 or placebo. Initial IRB, FDA and HRPO approval was given to recruit and screen subjects for 4 Cohorts (n=32) plus an option Cohort 5 (n=8) to be given a dose equal to, or less than, the dose given to Cohort 4. Cohorts 1-4 have been completed and no SAE's were noted. We submitted Amendment 4 to give a higher dose in Cohort 5 to the IRB and received approval (Amendments 1-3were minor and did not need approvals). We then submitted Amendment 4 to the FDA and have received no comments after two months. Amendment 4 was submitted to HRPO December 30, 2019 and received approval on January 7, 2020. Cohort 5 dosing was completed in February 2020. Data for entire Phase1 trial was locked on April 2, 2020.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 13, 2020
- Accession Number
- AD1119072
Entities
People
- Caron Shake
- Richard A. Clark