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

NCT02603224 | Completed Phase 1

• 1 other identifier: MRG201-30-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events

  Up to 43 days

Secondary Outcomes (2)

• Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses

  Up to 17 days

• Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses

  Up to 17 days

Other Outcomes (1)

• 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

  Up to 16 days

Study Arms (2)

MRG-201

EXPERIMENTAL

Drug: MRG-201

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MRG-201 DRUG

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

MRG-201

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males between 18 and 45 years of age inclusive
• Body Mass Index (BMI) 18-35 kg/m\^2 inclusive
• Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies
• If engaged in sexual relations with a female of child-bearing potential, must be willing to use two effective contraceptive methods throughout the treatment period and for at least 12 weeks after the last treatment administration

You may not qualify if:

• History of cutaneous disorder that could interfere with the study or put the subject at risk
• History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
• History of clinically significant anemia or evidence of clinically significant anemia at screening
• Positive for blood borne pathogen (HBV, HCV, HIV) at screening
• Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated)
• Use of systemic steroids or topical steroids on the target area within two months of the Baseline visit or use of topical steroids outside the target area within 14 days of the Baseline visit
• Use of an investigational small molecule drug within 28 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit

Sponsors & Collaborators

• miRagen Therapeutics, Inc.: lead

Study Sites (1)

Innovaderm Research, Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Study Officials

• Gilad S. Gordon, MD

  miRagen Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

CA (1)