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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2019-03-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Intervention Type DRUG

Multiple doses of Placebo

Interventions

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MRG-110

Single ascending doses of MRG-110

Intervention Type DRUG

Placebo

Single doses of placebo

Intervention Type DRUG

MRG-110

Multiple ascending doses of MRG-110

Intervention Type DRUG

Placebo

Multiple doses of Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes