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

NCT03639883 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-24

No results posted yet for this study

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)

Interventions

DRUG

AIV001

Intradermal injection

Sponsors & Collaborators

  • AiViva BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • James Milbauer, MD · Novella Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-12-04
Completion
2019-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639883 on ClinicalTrials.gov