Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
- Registration Number
- NCT01780077
- Lead Sponsor
- RXi Pharmaceuticals, Corp.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RXI-109 RXI-109 - RXI-109 Placebo - Placebo Placebo - Placebo RXI-109 -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of multiple intradermal administrations of RXI-109 12 weeks Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities
- Secondary Outcome Measures
Name Time Method To assess the effect of multiple intradermal administrations of RXI-109 on scar formation 12 weeks Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.