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Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

2014-08-27 03:14:06 | BioPortfolio

Summary

Primary Objective:

- Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.

Secondary Objective:

- Assess systemic exposure of SAR113945 following intra-articular delivery.

Description

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.

Study Design

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

Conditions

Osteoarthritis

Intervention

placebo, SAR113945

Location

Sanofi-Aventis Administrative Office
Berlin
Germany

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:06-0400

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