Overview

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

Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi