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

NCT02587442 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-10-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Original BioMedicals Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587442 on ClinicalTrials.gov