Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 45 |
| Updated: | 7/29/2018 |
| Start Date: | April 9, 2018 |
| End Date: | February 2019 |
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
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.
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.
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.
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