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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RXi Pharmaceuticals, Corp.

Criteria

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