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FGF-1

Phase 1

Chronic Wounds | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

FGF-1 · 2 trials · 6 indications

Phase 1 2
NCT00424866FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial DiseasePeripheral Arterial Disease
NOT YET_RECRUITING24 Analytics
NCT00425178FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis UlcersChronic Wounds
COMPLETED8 Analytics
PHASE1NOT YET_RECRUITING
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
Peripheral Arterial Disease
NCT0042486624
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PHASE1COMPLETED
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
Chronic Wounds
NCT004251788
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Study Endpoints

Primary Endpoints

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

Safety
Pharmacokinetics

Secondary Endpoints

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
Wound improvement
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORThe dosing groups correspond to total doses of 0 µg/kg of FGF-1.
Human FGF-1ACTIVE_COMPARATORThe dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.

Interventions

NameTypeDescription
FGF-1DRUGDoses 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
PlaceboDRUGVehicle: 0 µg/kg
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Eligibility Criteria

Age Range50 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 s...

Countries:United States
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