A Safety and Efficacy Study to Evaluate Wound Healing
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 3/6/2019 |
| Start Date: | November 5, 2018 |
| End Date: | December 2019 |
| Contact: | Maggie Volpe |
| Email: | Margaret.Volpe@NovellaClinical.com |
| Phone: | 201-473-4367 |
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
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of
the study medication compared with vehicle in subjects with incisional wounds
the study medication compared with vehicle in subjects with incisional wounds
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.
incisional wounds. Exploratory efficacy measures will also be collected as well as
pharmacokinetic profiles.
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
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