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

ConditionsPeripheral Arterial DiseaseStenosisIntermittent Claudication
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsorVenturis Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed.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.

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 fully able to comply with the protocol.

Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.

Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and <0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.

Disqualifiers

Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration

Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea

Lower limb amputation of, or in, either leg including toes

Evidence of limb ischemia from immunologic or inflammatory disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Human FGF-1Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)

Time frame
From enrollment through study completion, an average of 12 weeks
2

Change from baseline in safety laboratory measurements at 12 weeks

Safety laboratory evaluations on hematology, serum chemistry, and urinalysis

Time frame
From enrollment through study completion, an average of 12 weeks

Secondary outcomes

1

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

Pharmacokinetic plasma concentrations of FGF-1 (1-141)

Time frame
From enrollment through study completion, an average of 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Venturis Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: