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

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

Study Overview

• Status: Completed
• Conditions: Scar; Incision; Abdominal; Wound (Morphologic Abnormality)
• Intervention / Treatment: Drug: AIV001

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Folsom, California, United States, 95630
      • Kaufman and Davis Plastic Surgery
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.033% versus Vehicle; One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.	Drug: AIV001; Intradermal injection; Other Names: AIV001 suspension
Experimental: 0.1% versus Vehicle; One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.	Drug: AIV001; Intradermal injection; Other Names: AIV001 suspension
Experimental: 0.3% versus Vehicle; One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.	Drug: AIV001; Intradermal injection; Other Names: AIV001 suspension
Experimental: 1% versus Vehicle; One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.	Drug: AIV001; Intradermal injection; Other Names: AIV001 suspension

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AiViva BioPharma, Inc.
• Investigators: Study Director: James Milbauer, MD, Novella Clinical

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: wound healing; Scar; abdominoplasty
• Additional Relevant MeSH Terms: Surgical Wound; Wounds and Injuries
• Other Study ID Numbers: AIV001-W01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No