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Clinical Trial 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


Clinical Trial Description

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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01157143
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date January 2002
Completion date October 2003

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