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Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers

NCT02603224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-07-06

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. MRG-201 is being studied to determine if it can limit the formation of fibrous scar tissue in certain diseases.

MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a short skin incision. Volunteers may receive one or several doses of MRG-201, and will be monitored for local reactions in the skin, signs or symptoms of adverse effects on the body, and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to study how cells in the skin respond when exposed to MRG-201.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MRG-201

Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.

DRUG

Placebo

Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.

Sponsors & Collaborators

  • miRagen Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Gilad S. Gordon, MD · miRagen Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs

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 NCT02603224 on ClinicalTrials.gov