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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Single Ascending Dose - Placebo | Placebo Comparator | Intradermal injection of placebo at four wound sites |
|
| 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 |
|
| Multiple Ascending Dose - Placebo | Placebo Comparator | Intradermal injection of placebo at four wound sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG-110 | Drug | Single ascending doses of MRG-110 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. | Up to Day 55 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Escolar, MD | miRagen Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32105576 | Derived | 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. |
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| Placebo |
| Drug |
Single doses of placebo |
|
| MRG-110 | Drug | Multiple ascending doses of MRG-110 |
|
| Placebo | Drug | Multiple doses of Placebo |
|
| Up to Day 45 |
| Proportion of wounds closed over time | Up to Day 55 |