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- Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
- Assess systemic exposure of SAR113945 following intra-articular delivery.
The total study duration per subject ranges from 4 to 16 weeks broken down as follows:
- screening within 4 weeks before dosing,
- follow-up of 4 weeks (28 days) after the single dose of study medication,
- prolonged by a maximum of 8 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:14:06-0400
Study objectives: - Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR1...
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