A Safety and Efficacy Study to Evaluate Wound Healing

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639883
• Other study ID #: AIV001-W01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 5, 2018
• Est. completion date: December 19, 2019

Study information

• Verified date: April 2020
• Source: AiViva BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 19, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Drug:
• AIV001
Intradermal injection

Locations

Country	Name	City	State
United States	Cosmetic Laser Dermatology	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
AiViva BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Local and systemic adverse events	Day 1 through Day 49
Secondary	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
Secondary	Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)	Evaluation of the healing wounds	Day 7 through 49
Secondary	100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)	Evaluation of healing wounds	Day 7 through 49