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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603431
• Other study ID #: MRG110-01-001
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2018
• Est. completion date: March 13, 2019

Study information

• Verified date: May 2019
• Source: miRagen Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Key Inclusion Criteria:

• Normal healthy volunteers.

• Females must be of non-childbearing potential.

• If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.

• Must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies.

• Must have no conditions that could increase risk of abnormal or delayed healing.

Key Exclusion Criteria:

• Clinically significant abnormalities in medical history or physical examination.

• Clinically significant abnormalities in laboratory tests at screening.

• History of cutaneous disorder.

• Hemangioma, history of hemangioblastoma, or other known vascular disorder.

• Positive for bloodborne pathogen (hepatitis B, hepatitis C, HIV).

• Use of an investigational drug or device within 28 days prior to Day 1, or use of an investigational biological or oligonucleotide drug within 90 days of Day 1.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• MRG-110
Single ascending doses of MRG-110
• Placebo
Single doses of placebo
• MRG-110
Multiple ascending doses of MRG-110
• Placebo
Multiple doses of Placebo

Locations

Country	Name	City	State
United States	Celerion, Inc.	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
miRagen Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area of granulation tissue formation		Day 11 or Day 18
Other	Histological markers of angiogenesis (such as CD31, ERG, ITGA5)		Day 11 or Day 18
Other	Wound perfusion measured by laser speckle imaging		Up to Day 45
Other	Proportion of wounds closed over time		Up to Day 55
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.		Up to Day 55
Secondary	Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.		Up to Day 45
Secondary	Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses		Up to Day 45