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

RXi Pharmaceuticals, Corp.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cicatrix Scar Prevention

Interventions

RXI-109DRUG

Multiple intradermal injections of RXI-109 at incision sites

PlaceboDRUG

Multiple intradermal injections of placebo at incision sites

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple intradermal administrations of RXI-109

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

Time frame: 12 weeks

Secondary Outcomes

To assess the effect of multiple intradermal administrations of RXI-109 on scar formation

Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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