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
Venturis Therapeutics, Inc.
Summary
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.
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.
Eligibility
- Age range
- 50–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent. 2. Age must be ≥50 and ≤75 years of age with a life expectancy of \> 1 year and leg survival \> 6 months. Patients \>75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fu…
Interventions
- DrugFGF-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
- DrugPlacebo
Vehicle: 0 µg/kg
Location
- Venturis TherapeuticsChicago, Illinois