NCT02587442

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Original BioMedicals Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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).

Conditions

• Acute Radiation Syndrome

Interventions

Type	Name	Description
DRUG	RadProtect®	This study will evaluate RadProtect® at sequential, escalating dose levels. Once administration is given, study subjects will be followed during 24 hours of hospitalization according to the final injection timing. All subjects will need to return to the hospital for monitoring at 7+2 days after dosing, and follow-up visits by telephone at Day 3, Day 14+2, and Day 28+2 days will need to be conducted.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• First posted: 2015-10-27
• Last updated: 2015-10-27

Locations

1 site across 1 country: United States