NCT04267640

Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AnGes USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor \[HGF\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

Detailed description

This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups: * 4.0 mg AMG0001 intramuscular (IM) (n = 20) * 8.0 mg AMG0001 IM (n = 20) * Placebo IM (n = 20)

Conditions

• Peripheral Artery Disease
• Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
• Chronic Limb Threatening Ischemia
• Ischemic Ulcer of Foot

Interventions

Type	Name	Description
BIOLOGICAL	AMG0001	AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
BIOLOGICAL	Placebo	Matching placebo

Timeline

• Start date: 2020-01-30
• Primary completion: 2022-07-01
• Completion: 2023-01-01
• First posted: 2020-02-13
• Last updated: 2021-12-22

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study