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NCT06159452

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
Sanofi·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Rheumatoid Arthritis
Drug/Device/Intervention
SAR153191-P3 drug product
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sanofi
Timeline & enrollment
Phase
Phase 1
Start date
Jul 09, 2010
End date
Dec 21, 2010
Enrollment
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, unspecifiedOther rheumatoid arthritisOther specified rheumatoid arthritisRheumatoid arthritis with involvement of other organs and systemsSeronegative rheumatoid arthritis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06159452
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.