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

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ClinicalTrials.gov Identifier: NCT03603431
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: MRG-110 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Single Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
Drug: MRG-110
Single ascending doses of MRG-110

Drug: Placebo
Single doses of placebo

Placebo Comparator: Single Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
Drug: Placebo
Single doses of placebo

Experimental: Multiple Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
Drug: MRG-110
Multiple ascending doses of MRG-110

Drug: Placebo
Multiple doses of Placebo

Placebo Comparator: Multiple Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
Drug: Placebo
Multiple doses of Placebo




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. [ Time Frame: Up to Day 55 ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603431


Locations
United States, Nebraska
Celerion, Inc. Recruiting
Lincoln, Nebraska, United States, 68502
Contact: Philip Mathew, MD    402-476-2811    philip.mathew@celerion.com   
Sponsors and Collaborators
miRagen Therapeutics, Inc.
Investigators
Study Director: Diana Escolar, MD miRagen Therapeutics, Inc.

Responsible Party: miRagen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03603431     History of Changes
Other Study ID Numbers: MRG110-01-001
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by miRagen Therapeutics, Inc.:
Healthy Volunteers
MicroRNAs
Angiogenesis Inducing Agents