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

Phase 1

• Conditions: Peripheral Arterial Disease; Stenosis; Intermittent Claudication
• Interventions: Drug: Placebo; Drug: FGF-1

• Registration Number: NCT00424866
• Lead Sponsor: CardioVascular BioTherapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Study Start: 2020-12
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The dosing groups correspond to total doses of 0 µg/kg of FGF-1.
Human FGF-1	FGF-1	The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability of i.m. injected Cardio Vascu Grow TM, a recombinant Human Fibroblast Growth Factor-1 (FGF-1-141)	From enrollment through study completion, an average of 12 weeks	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Change from baseline in safety laboratory measurements at 12 weeks	From enrollment through study completion, an average of 12 weeks	Safety laboratory evaluations on hematology, serum chemistry, and urinalysis

Secondary Outcome Measures

Name	Time	Method
Plasma FGF-1 (1-141) pharmacokinetic measurements at pre-dose, 5, 15, and 30 minutes and at 1, 2, 4, 6, 10, and 24 hours	From enrollment through study completion, an average of 12 weeks	Pharmacokinetic plasma concentrations of FGF-1 (1-141)

Trial Locations

Locations (1)

CVBT Info; 🇺🇸 Dallas, Texas, United States