NCT00424866

FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: CardioVascular BioTherapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.

Detailed description

FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.

Conditions

• Peripheral Arterial Disease
• Stenosis
• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	FGF-1	Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg
DRUG	Placebo	Vehicle: 0 µg/kg

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2007-01-22
• Last updated: 2019-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study