Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

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

Details

• Lead Sponsor: RXi Pharmaceuticals, Corp.

Criteria

Inclusion Criteria:

• Males and females, 21-50 years of age

• General good health; if female not pregnant or lactating

• Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

• Pregnant or lactating

• Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study

• Type 1 or 2 diabetes mellitus

• A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator