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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03639883
Other study ID # AIV001-W01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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