CompletedPhase 1/2

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

United States16 participantsStarted 2018-11-05

Plain-language summary

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

Who can participate

Age range21 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse events

Timeframe: Day 1 through Day 49

Trial details

NCT IDNCT03639883

SponsorAiViva BioPharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-04

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