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OpenTrials
Completed

NCT Number: NCT03603431

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

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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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRG-110

Drug

Single ascending doses of MRG-110

Placebo

Drug

Single doses of placebo

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.

    Time frame: Up to Day 55

Secondary outcomes

  1. Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.

    Time frame: Up to Day 45

  2. Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses

    Time frame: Up to Day 45

Other outcomes

  1. Area of granulation tissue formation

    Time frame: Day 11 or Day 18

  2. Histological markers of angiogenesis (such as CD31, ERG, ITGA5)

    Time frame: Day 11 or Day 18

  3. Wound perfusion measured by laser speckle imaging

    Time frame: Up to Day 45

  4. Proportion of wounds closed over time

    Time frame: Up to Day 55

Sponsors and collaborators

Lead sponsor

miRagen Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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