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

AiViva BioPharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Wound (Morphologic Abnormality); Abdominal; Incision; Scar

Treatments: Drug: AIV001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03639883

AIV001-W01

Details and patient eligibility

About

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

Full description

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Enrollment: 16 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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16 participants in 4 patient groups

0.033% versus Vehicle

Experimental group

Description:

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

Treatment:

Drug: AIV001

0.1% versus Vehicle

Experimental group

Description:

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

Treatment:

Drug: AIV001

0.3% versus Vehicle

Experimental group

Description:

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

Treatment:

Drug: AIV001

1% versus Vehicle

Experimental group

Description:

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

Treatment:

Drug: AIV001