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

RXi Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cicatrix; Scar Prevention

Treatments: Drug: Placebo; Drug: RXI-109

Study type: Interventional

Funder types: Industry

Identifiers

NCT01780077

RXI-109-1202

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

RXI-109

Experimental group

Treatment:

Drug: Placebo

Drug: RXI-109

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: RXI-109