NCT03585803

A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011

A Dose Blocked-Randomized, Single-Blind, Placebo-Controlled and Dose-Escalation Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011 After Intramuscular Administration in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Intron Biotechnology, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.

Conditions

• Acute Radiation Syndrome

Interventions

Type	Name	Description
DRUG	KMRC011 5μg or Placebo	Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml
DRUG	KMRC011 10μg or Placebo	Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml
DRUG	KMRC011 15μg or Placebo	Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml
DRUG	KMRC011 20μg or Placebo	Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml
DRUG	KMRC011 25μg or Placebo	Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-09-11
• Completion: 2019-11-28
• First posted: 2018-07-13
• Last updated: 2021-02-01

Locations

1 site across 1 country: South Korea