Healthy Volunteer
Conditions
Keywords
Healthy Volunteers, MicroRNAs, Angiogenesis Inducing Agents
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.
Interventions
DRUGMRG-110
Single ascending doses of MRG-110
DRUGPlacebo
Single doses of placebo
Sponsors
miRagen Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. | Up to Day 55 |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Area of granulation tissue formation | Day 11 or Day 18 |
| Proportion of wounds closed over time | Up to Day 55 |
| 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 |
Countries
United States
Outcome results
None listed