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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159452
• Other study ID #: TDU11373
• Secondary ID: U1111-1293-6227
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2010
• Est. completion date: December 21, 2010

Study information

• Verified date: November 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Up to 35 Days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 21, 2010
• Est. primary completion date: December 21, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SAR153191-P3 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
• SAR153191-P2 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
• SAR153191-C1F3 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics: t1/2z	Terminal half-life associated with the terminal slope (?z)	At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Secondary	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
Secondary	Incidence of anti-SAR153191 antibodies		At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive)