drugset / Trial / NCT02603224

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

NCT02603224 ↗

Phase 1 Completed 54 enrolled miRagen Therapeutics, Inc.
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Remlarsen Unknown — Other

Indications

No indication recorded.