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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SAR153191-P3 drug product; Drug: SAR153191-P2 drug product; Drug: SAR153191-C1F3 drug product

Detailed Description

Up to 35 Days

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; SAR153191 - P3 drug product concentration 1 dose 1	Drug: SAR153191-P3 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Experimental: Group B; SAR153191 - P2 drug product concentration 2 dose 2	Drug: SAR153191-P2 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Experimental: Group C; SAR153191 - P3 drug product concentration 2 dose 2	Drug: SAR153191-P3 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Experimental: Group D; SAR153191 - P3 drug product concentration 3 dose 3	Drug: SAR153191-P3 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Experimental: Group B'; SAR153191 - P2 drug product concentration 2 dose 3	Drug: SAR153191-P2 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Experimental: Group C'; SAR153191 - P3 drug product concentration 2 dose 3	Drug: SAR153191-P3 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191
Active Comparator: Group E'; SAR153191 - CIF3 drug product concentration 2 dose 3	Drug: SAR153191-C1F3 drug product; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Other Names: SAR153191

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting injection site reactions	Injection site reactions include pain, erythema an edema.	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Cmax	Maximum plasma concentration observed	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: tmax	First time to reach Cmax	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUClast	Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUC	Area under the plasma concentration versus time curve extrapolated to infinity	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: t1/2z	Terminal half-life associated with the terminal slope (λz)	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)		Up to 35 Days
Incidence of anti-SAR153191 antibodies		At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2010
• Primary Completion (Actual): December 21, 2010
• Study Completion (Actual): December 21, 2010

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Estimated): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: TDU11373; U1111-1293-6227 (Registry Identifier: ICTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No