Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers

Study Design:

Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending doses of MRG-201 by intradermal injection at one site and placebo at a second site over a period of up to 15 days, with follow-up for up to 28 days after the last dose to determine the maximum tolerated dose in intact or incised normal skin and the tendency for active drug to diffuse through the skin.

Inclusion criteria

• Healthy males between 18 and 45 years of age inclusive
• Body Mass Index (BMI) 18-35 kg/m^2 inclusive
• Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies
• If engaged in sexual relations with a female of child-bearing potential, must be willing to use two effective contraceptive methods throughout the treatment period and for at least 12 weeks after the last treatment administration

Exclusion criteria

• Clinically significant abnormalities in medical history or physical exam which in the opinion of the Investigator would make the subject unsuitable for inclusion in the study
• History of cutaneous disorder that could interfere with the study or put the subject at risk
• History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
• History of clinically significant anemia or evidence of clinically significant anemia at screening
• Positive for blood borne pathogen (HBV, HCV, HIV) at screening
• Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated)
• Use of systemic steroids or topical steroids on the target area within two months of the Baseline visit or use of topical steroids outside the target area within 14 days of the Baseline visit
• Use of an investigational small molecule drug within 28 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit