A Safety and Efficacy Study to Evaluate Wound Healing

Study Overview
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Brief Summary
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To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

Detailed Description
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This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.

Official Title
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A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in the Healing of Incisional Wounds

Conditions
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Wound Heal

Intervention / Treatment
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* Drug: AIV001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for an abdominoplasty Nonsmoker Fitzpatrick I-IV Weight >45Kg BMI <= 35 Exclusion Criteria: Existing scars in study area, active infection Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: Sequential Assignment
Interventional Model Description: Randomized, double-blind, vehicle-controlled, dose-escalation
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.033% versus Vehicle<br>One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle. | Drug: AIV001<br>* Intradermal injection<br>* Other names: AIV001 suspension;|
| Placebo Comparator: 0.1% versus Vehicle<br>One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle. | Drug: AIV001<br>* Intradermal injection<br>* Other names: AIV001 suspension;|
| Placebo Comparator: 0.3% versus Vehicle<br>One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle. | Drug: AIV001<br>* Intradermal injection<br>* Other names: AIV001 suspension;|
| Placebo Comparator: 1% versus Vehicle<br>One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle. | Drug: AIV001<br>* Intradermal injection<br>* Other names: AIV001 suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Local and systemic adverse events | Day 1 through Day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable) | Evaluation of the healing of the wounds | Day 7 through 49 | 
| Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe) | Evaluation of the healing wounds | Day 7 through 49 | 
| 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar) | Evaluation of healing wounds | Day 7 through 49 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing