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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RXI-109 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXI-109 | Drug | Multiple intradermal injections of RXI-109 at incision sites |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the timeline and levels of biomarkers | Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Multiple intradermal injections of placebo at incision sites |
|