Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers (NCT03603431)

01

Study 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.

02

Conditions studied

Healthy Volunteer

Keywords

Healthy Volunteers
MicroRNAs
Angiogenesis Inducing Agents

03

Who can participate

Ages eligible: 19 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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.

04

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 42 participants (actual)

Study arms

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 · Drug: Placebo
Placebo comparator
Single Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
Drug: 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 · Drug: Placebo
Placebo comparator
Multiple Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
Drug: Placebo

Interventions

DrugMRG-110
Single ascending doses of MRG-110
DrugPlacebo
Single doses of placebo
DrugMRG-110
Multiple ascending doses of MRG-110
DrugPlacebo
Multiple doses of Placebo

05

What researchers measure

Primary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Time frame: Up to Day 55

Secondary outcomes

Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.
Time frame: Up to Day 45
Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses
Time frame: Up to Day 45

Other outcomes

Area of granulation tissue formation
Time frame: Day 11 or Day 18
Histological markers of angiogenesis (such as CD31, ERG, ITGA5)
Time frame: Day 11 or Day 18
Wound perfusion measured by laser speckle imaging
Time frame: Up to Day 45
Proportion of wounds closed over time
Time frame: Up to Day 55

06

Study locations

1 site

Celerion, Inc.
Lincoln, Nebraska 68502, United States

07

References and documents

Publications

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. PubMed 32105576 ↗

08

Registry details

Key details

Study ID: NCT03603431
Lead sponsor: miRagen Therapeutics, Inc.
Responsible party: Sponsor
First posted: Jul 27, 2018
Start date: Apr 9, 2018
Primary completion: Mar 13, 2019
Completion: Mar 13, 2019
Last update: May 7, 2019

Study contacts

Diana Escolar, MD

study director · miRagen Therapeutics, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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