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

miRagen Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: MRG-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT03603431

MRG110-01-001

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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42 participants in 4 patient groups, including a placebo group

Single Ascending Dose - MRG-110

Experimental group

Description:

Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites

Treatment:

Drug: Placebo

Drug: MRG-110

Drug: Placebo

Drug: MRG-110

Single Ascending Dose - Placebo

Placebo Comparator group

Description:

Intradermal injection of placebo at four wound sites

Treatment:

Drug: Placebo

Drug: Placebo

Multiple Ascending Dose - MRG-110

Experimental group

Description:

Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites

Treatment:

Drug: Placebo

Drug: MRG-110

Drug: Placebo

Drug: MRG-110

Multiple Ascending Dose - Placebo

Placebo Comparator group

Description:

Intradermal injection of placebo at four wound sites

Treatment:

Drug: Placebo

Drug: Placebo