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

NCT03585803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-02-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Intron Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Jung-Ryul Kim, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-09-11
Completion
2019-11-28

Countries

  • South Korea

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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 NCT03585803 on ClinicalTrials.gov