NCT01780077
Completed
Phase 1
A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects
RXi Pharmaceuticals, Corp.0 sites15 target enrollmentDecember 2012
Overview
- Phase
- Phase 1
- Intervention
- RXI-109
- Conditions
- Cicatrix
- Sponsor
- RXi Pharmaceuticals, Corp.
- Enrollment
- 15
- Primary Endpoint
- To assess the safety and tolerability of multiple intradermal administrations of RXI-109
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
RXI-109
Intervention: RXI-109
RXI-109
Intervention: Placebo
Placebo
Intervention: RXI-109
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
To assess the safety and tolerability of multiple intradermal administrations of RXI-109
Time Frame: 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 Outcomes
- To assess the effect of multiple intradermal administrations of RXI-109 on scar formation(12 weeks)
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