Overview
A Safety and Efficacy Study to Evaluate Wound Healing
Status:
Completed
Completed
Trial end date:
2019-12-19
2019-12-19
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional woundsPhase:
Phase 1/Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Aiviva BioPharma Inc.
AiViva BioPharma, Inc.
Criteria
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