Accession Number:

AD1158829

Title:

A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability and Pharmacokinetics of cP12 in Healthy Adults

Descriptive Note:

[Technical Report, Annual Report]

Corporate Author:

Neomatrix Therapeutics, Inc

Personal Author(s):

Report Date:

2021-10-01

Pagination or Media Count:

23

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 n32 plus an option Cohort 5 n8 to be given a dose equal to, or less than, the dose given to Cohort 4. Cohorts 1-4 have been completed and no SAEs were noted. We submitted Amendment 4 to give a higher dose in Cohort 5 to the IRB and received approval Amendments 1-3 were 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

Descriptors:

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

[A, Approved For Public Release]