NCT03603431

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of MRG-110 Following Local Intradermal Injection After Skin Excisional Wound Creation in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: miRagen Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	MRG-110	Single ascending doses of MRG-110
DRUG	Placebo	Single doses of placebo
DRUG	MRG-110	Multiple ascending doses of MRG-110
DRUG	Placebo	Multiple doses of Placebo

Timeline

• Start date: 2018-04-09
• Primary completion: 2019-03-13
• Completion: 2019-03-13
• First posted: 2018-07-27
• Last updated: 2019-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study