Clinical Trial: A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
Brief Summary: This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).
Detailed Summary:
Sponsor: Original BioMedicals Co. Ltd.
Current Primary Outcome: Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers. [ Time Frame: Day 0~ Day 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points. [ Time Frame: Day 0 ~ Day 1 (24 hours after dosing) ]
Original Secondary Outcome: Same as current
Information By: Original BioMedicals Co. Ltd.
Dates:
Date Received: October 26, 2015
Date Started: October 2015
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015