Overview
Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
Status:
Completed
Completed
Trial end date:
2014-11-01
2014-11-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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