drugset / Trial / 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

NCT06159452

Phase 1 Completed 53 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-07-09
Primary completion
2010-12-21
Completion
2010-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Sarilumab Monoclonal antibody Subcutaneous

Indications