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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

NCT ID: NCT06159452

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-09

Study Completion Date

2010-12-21

Brief Summary

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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.

Detailed Description

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Up to 35 Days

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A

SAR153191 - P3 drug product concentration 1 dose 1

Group Type EXPERIMENTAL

SAR153191-P3 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group B

SAR153191 - P2 drug product concentration 2 dose 2

Group Type EXPERIMENTAL

SAR153191-P2 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group C

SAR153191 - P3 drug product concentration 2 dose 2

Group Type EXPERIMENTAL

SAR153191-P3 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group D

SAR153191 - P3 drug product concentration 3 dose 3

Group Type EXPERIMENTAL

SAR153191-P3 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group B'

SAR153191 - P2 drug product concentration 2 dose 3

Group Type EXPERIMENTAL

SAR153191-P2 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group C'

SAR153191 - P3 drug product concentration 2 dose 3

Group Type EXPERIMENTAL

SAR153191-P3 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Group E'

SAR153191 - CIF3 drug product concentration 2 dose 3

Group Type ACTIVE_COMPARATOR

SAR153191-C1F3 drug product

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Interventions

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SAR153191-P3 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Intervention Type DRUG

SAR153191-P2 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Intervention Type DRUG

SAR153191-C1F3 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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SAR153191 SAR153191 SAR153191

Eligibility Criteria

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Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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U1111-1293-6227

Identifier Type: REGISTRY

Identifier Source: secondary_id

TDU11373

Identifier Type: -

Identifier Source: org_study_id