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SAR153191-P3 drug product
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
Ensayo de Sanofi en Artritis reumatoide.
Más ensayos de: Artritis reumatoide.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 53
- Fin del objetivo primario
- dic 2010
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en jul 2010.
Qué mide
Number of participants reporting injection site reactions (At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06159452), actualizada en nov 2023.