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 ]

DLT is defined as a subject's symptom worse than a Grade 2, with the exception of the value for Total Protein and Cholesterol that should be determined by the investigator as these values may be affected by diet and there may be no discomfort or immediate risk for subjects. During the telephone visits on Day 3, 14+2, and 28+2 after injection, the study coordinator will confirm the subject's status, report to the investigators, and will schedule extra hospital visits if necessary.


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) ]

PK samples will be obtained from the arm opposite the side of infusion. A total of approximately 4 mL of whole blood per collection time point per subject will be collected for the PK analysis. There will be a total of 10 or 16 times during this study when the sampling times for PK analysis will take place (this will depend on the dosing group).


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