A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers

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).

Timeline

Start

2015-10

Primary completion

2016-03

Completion

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Publications

• Background Chen CH, Kuo ML, Wang JL, Liao WC, Chang LC, Chan LP, Lin J. CCM-AMI, a Polyethylene Glycol Micelle with Amifostine, as an Acute Radiation Syndrome Protectant in C57BL/6 Mice. Health Phys. 2015 Sep;109(3):242-8. doi: 10.1097/HP.0000000000000326.

Drugs

Indications