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Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects - Trial NCT06159452

Access comprehensive clinical trial information for NCT06159452 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sanofi and is currently Completed. The study focuses on Rheumatoid Arthritis. Target enrollment is 53 participants.

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NCT06159452
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06159452
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Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects
Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses, in Healthy Male Subjects

Study Focus

Rheumatoid Arthritis

SAR153191-P3 drug product

Interventional

drug

Sponsor & Location

Sanofi

Timeline & Enrollment

Phase 1

Jul 09, 2010

Dec 21, 2010

53 participants

Primary Outcome

Number of participants reporting injection site reactions

Summary

Primary objective:
 
 To determine the tolerability of different SAR153191 drug products that differ with respect
 to manufacturing processes and formulation, at different concentrations and doses, after
 administration of single subcutaneous doses to healthy male subjects.
 
 Secondary objectives:
 
 To determine the pharmacokinetic profile of the different SAR153191 drug products
 administered subcutaneously.
 
 To assess the safety of the different SAR153191 drug products administered subcutaneously.

ICD-10 Classifications

Rheumatoid arthritis, unspecified
Other rheumatoid arthritis
Other specified rheumatoid arthritis
Rheumatoid arthritis with involvement of other organs and systems
Seronegative rheumatoid arthritis

Data Source

ClinicalTrials.gov

NCT06159452

Non-Device Trial