Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109

A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty

The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.

Inclusion Criteria:

• Subject must be a female in general good health with normal screening values
• Subject must be a good surgical candidate for an elective abdominoplasty
• Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)

Exclusion Criteria:

• Currently pregnant or lactating
• BMI greater than 35 at screening
• Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
• Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI