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A Safety and Efficacy Study to Evaluate Wound Healing

Sponsor
AiViva BioPharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03639883
Collaborator
(none)
16
Enrollment
1
Location
4
Arms
13.4
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Randomized, double-blind, vehicle-controlled, dose-escalationRandomized, double-blind, vehicle-controlled, dose-escalation
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 5, 2018
Actual Primary Completion Date :
Dec 4, 2019
Actual Study Completion Date :
Dec 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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

    		•
    Placebo Comparator: 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

    		•
    Placebo Comparator: 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

    		•
    Placebo Comparator: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events [Day 1 through Day 49]

      Local and systemic adverse events

    Secondary Outcome Measures

    1. Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable) [Day 7 through 49]

      Evaluation of the healing of the wounds

    2. Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe) [Day 7 through 49]

      Evaluation of the healing wounds

    3. 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar) [Day 7 through 49]

      Evaluation of healing wounds

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cosmetic Laser Dermatology San Diego California United States 92121

    Sponsors and Collaborators

    • AiViva BioPharma, Inc.

    Investigators

    • Study Director: James Milbauer, MD, Novella Clinical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AiViva BioPharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT03639883
    Other Study ID Numbers:
    • AIV001-W01
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AiViva BioPharma, Inc.
    wound healing
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 14, 2020