NCT03603431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

July 9, 2018

Last Update Submit

May 3, 2019

Conditions

Healthy Volunteer

Keywords

Healthy VolunteersMicroRNAsAngiogenesis Inducing Agents

Outcome Measures

Primary Outcomes (1)

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

    Up to Day 55

Secondary Outcomes (2)

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

    Up to Day 45

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

    Up to Day 45

Other Outcomes (4)

  • Area of granulation tissue formation

    Day 11 or Day 18

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

    Day 11 or Day 18

  • Wound perfusion measured by laser speckle imaging

    Up to Day 45

  • +1 more other outcomes

Study Arms (4)

Single Ascending Dose - MRG-110

EXPERIMENTAL

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

Drug: MRG-110Drug: Placebo

Single Ascending Dose - Placebo

PLACEBO COMPARATOR

Intradermal injection of placebo at four wound sites

Drug: Placebo

Multiple Ascending Dose - MRG-110

EXPERIMENTAL

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

Drug: MRG-110Drug: Placebo

Multiple Ascending Dose - Placebo

PLACEBO COMPARATOR

Intradermal injection of placebo at four wound sites

Drug: Placebo

Interventions

MRG-110DRUG

Single ascending doses of MRG-110

Single Ascending Dose - MRG-110
PlaceboDRUG

Single doses of placebo

Single Ascending Dose - MRG-110Single Ascending Dose - Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

  • Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.

    PMID: 32105576DERIVED

Study Officials

  • Diana Escolar, MD

    miRagen Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 27, 2018

Study Start

April 9, 2018

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

US(1)