NCT03639883

A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AiViva BioPharma, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Conditions

• Scar
• Incision
• Abdominal
• Wound (Morphologic Abnormality)

Interventions

Type	Name	Description
DRUG	AIV001	Intradermal injection

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-12-04
• Completion: 2019-12-19
• First posted: 2018-08-21
• Last updated: 2024-12-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study