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

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SAR153191-P3 drug product; Drug: SAR153191-P2 drug product; Drug: SAR153191-C1F3 drug product

Study type: Interventional

Funder types: Industry

Identifiers

NCT06159452

TDU11373

U1111-1293-6227 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Up to 35 Days

Enrollment: 53 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 7 patient groups

Group A

Experimental group

Description:

SAR153191 - P3 drug product concentration 1 dose 1

Treatment:

Drug: SAR153191-P3 drug product

Group B

Experimental group

Description:

SAR153191 - P2 drug product concentration 2 dose 2

Treatment:

Drug: SAR153191-P2 drug product

Group C

Experimental group

Description:

SAR153191 - P3 drug product concentration 2 dose 2

Treatment:

Drug: SAR153191-P3 drug product

Group D

Experimental group

Description:

SAR153191 - P3 drug product concentration 3 dose 3

Treatment:

Drug: SAR153191-P3 drug product

Group B'

Experimental group

Description:

SAR153191 - P2 drug product concentration 2 dose 3

Treatment:

Drug: SAR153191-P2 drug product

Group C'

Experimental group

Description:

SAR153191 - P3 drug product concentration 2 dose 3

Treatment:

Drug: SAR153191-P3 drug product

Group E'

Active Comparator group

Description:

SAR153191 - CIF3 drug product concentration 2 dose 3

Treatment:

Drug: SAR153191-C1F3 drug product