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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603224
• Other study ID #: MRG201-30-001
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2015
• Last updated: July 5, 2017
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: miRagen Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Design:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Clinically significant abnormalities in medical history or physical exam which in the opinion of the Investigator would make the subject unsuitable for inclusion in the study

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• MRG-201
Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.
• Placebo
Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.

Locations

Country	Name	City	State
Canada	Innovaderm Research, Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
miRagen Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses		Up to 17 days
Secondary	Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses		Up to 17 days