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A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers

Traumatic Brain Injury (TBI) Clinical Trial

Official title:
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of a Single Dose of PRV-002 in Healthy Volunteers.

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers

Clinical Trial Description

This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of different dose levels of PRV-002 in Healthy Volunteers. The study will evaluate 3 dose levels of the investigational product, PRV-002, in 3 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05033444
Study type Interventional
Source Odyssey Group International, Inc.
Contact Mike Lewandowski, BS
Phone 7276926196
Email mlewandowski@odysseygi.com
Status Recruiting
Phase Phase 1
Start date September 17, 2021
Completion date November 30, 2021
View Details
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