Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of MRG-201 Following Local Intradermal Injection in Normal Healthy Volunteers|
- Safety and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events [ Time Frame: Up to 43 days ]
- Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses [ Time Frame: Up to 17 days ]
- Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses [ Time Frame: Up to 17 days ]
- Exploratory assessment of the levels of miR-29 target mRNAs in skin following treatment with MRG-201 or placebo using the Nanostring nCounter® analysis system [ Time Frame: Up to 16 days ]
|Study Start Date:||November 2015|
|Study Completion Date:||April 2017|
|Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.
|Placebo Comparator: Placebo||
Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.
Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending doses of MRG-201 by intradermal injection at one site and placebo at a second site over a period of up to 15 days, with follow-up for up to 28 days after the last dose to determine the maximum tolerated dose in intact or incised normal skin and the tendency for active drug to diffuse through the skin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02603224
|Innovaderm Research, Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Study Director:||Gilad S. Gordon, MD||miRagen Therapeutics, Inc.|