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

NCT03639883 | Completed Phase 1 FDA Drug

• 1 other identifier: AIV001-W01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Scar; Incision; Abdominal; Wound (Morphologic Abnormality)

Keywords

wound healing; Scar; abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Local and systemic adverse events

  Day 1 through Day 49

Secondary Outcomes (3)

• Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)

  Day 7 through 49

• Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)

  Day 7 through 49

• 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)

  Day 7 through 49

Study Arms (4)

0.033% versus Vehicle

EXPERIMENTAL

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

Drug: AIV001

0.1% versus Vehicle

EXPERIMENTAL

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

Drug: AIV001

0.3% versus Vehicle

EXPERIMENTAL

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

Drug: AIV001

1% versus Vehicle

EXPERIMENTAL

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

Drug: AIV001

Interventions

AIV001 DRUG

Intradermal injection

Also known as: AIV001 suspension

0.033% versus Vehicle; 0.1% versus Vehicle; 0.3% versus Vehicle; 1% versus Vehicle

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible for an abdominoplasty
• Nonsmoker
• Fitzpatrick I-IV
• Weight \>45Kg
• BMI \<= 35

You may not qualify if:

• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (2)

Kaufman and Davis Plastic Surgery

Folsom, California, 95630, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cicatrix; Surgical Wound; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Milbauer, MD

  Novella Clinical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, vehicle-controlled, dose-escalation

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: November 5, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 19, 2019
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)