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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Venturis Therapeutics, Inc.
Study ID
NCT00424866
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Intermittent Claudication
  • Peripheral Arterial Disease
  • Stenosis

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FGF-1 — DRUG
    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
  • Placebo — DRUG
    Vehicle: 0 µg/kg

Study Details

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

Key Dates

First listed
Jan 22, 2007
Start date
Oct 15, 2028
Status verified
Aug 2026
Primary completion
Feb 5, 2030
Completion
Dec 15, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    The dosing groups correspond to total doses of 0 µg/kg of FGF-1.
  • Active Comparator: Human FGF-1
    The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.

Primary Outcome Measure

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) [ Time Frame: From enrollment through study completion, an average of 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Venturis TherapeuticsChicagoIllinois60611-

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By research site
Venturis Therapeutics· Chicago, IL

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