Peripheral Arterial Occlusive Disease Clinical Trial
Official title:
Phase I, Double Blind, Parallel-Group, Multi-center, Gene Expression (Synthesis of FGF-1 mRNA) and Tolerability Study of Increasing Single Dose of NV1FGF Administered by Intra-Muscular Injection in Subjects With Severe Peripheral Artery Occlusive Disease (PAOD) Planned to Undergo Amputation Above the Ankle
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in
injected tissue, at injection site, after Intra Muscular (IM) administration of increasing
single doses of NV1FGF.
Secondary objectives :
- To evaluate the safety and tolerability of IM administration of increasing single doses
of NV1FGF
- To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection
site and remote site)
- To evaluate the presence of FGF-1 receptors in injected tissues (injection site and
remote site)
- To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote
site), in multiple organs/tissues when appropriate, and plasma
- To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at
remote site
- To collect data from plasma NV1FGF pharmacokinetics
- To evaluate healing of the amputation site
Screening of 1 to 4 weeks before study drug administration; Single study drug administration 3 to 8 days before planned amputation; 6 months of follow up ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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