Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2002
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
Epistemonikos ID: 8d22061b00b161c86dc8f0fcd79d3f54202aa04b
First added on: May 05, 2024