Trial | NCT03639883  Report issue

Title

A Safety and Efficacy Study to Evaluate Wound Healing
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    AIV001

  • Study Participants

    16
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of 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.
Study Started
Nov 05
2018
Primary Completion
Dec 04
2019
Study Completion
Dec 19
2019
Last Update
Jul 14
2020

Drug AIV001

Intradermal injection

  • Other names: AIV001 suspension

0.033% versus Vehicle Placebo Comparator

One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.

0.1% versus Vehicle Placebo Comparator

One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.

0.3% versus Vehicle Placebo Comparator

One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.

1% versus Vehicle Placebo Comparator

One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.

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
No Results Posted