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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cicatrix, Scar Prevention

Intervention / Treatment
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* Drug: RXI-109
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RXI-109<br> | Drug: RXI-109<br>* Multiple intradermal injections of RXI-109 at incision sites<br>Drug: Placebo<br>* Multiple intradermal injections of placebo at incision sites<br>|
| Placebo Comparator: Placebo<br> | Drug: RXI-109<br>* Multiple intradermal injections of RXI-109 at incision sites<br>Drug: Placebo<br>* Multiple intradermal injections of placebo at incision sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scar, Scar prevention, Fibrosis