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
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: SAR153191-P3 drug productDrug: SAR153191-P2 drug productDrug: SAR153191-C1F3 drug product
- Registration Number
- NCT06159452
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Up to 35 Days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 53
- Having given written informed consent prior to any procedure related to the study.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A SAR153191-P3 drug product SAR153191 - P3 drug product concentration 1 dose 1 Group B SAR153191-P2 drug product SAR153191 - P2 drug product concentration 2 dose 2 Group D SAR153191-P3 drug product SAR153191 - P3 drug product concentration 3 dose 3 Group B' SAR153191-P2 drug product SAR153191 - P2 drug product concentration 2 dose 3 Group C SAR153191-P3 drug product SAR153191 - P3 drug product concentration 2 dose 2 Group C' SAR153191-P3 drug product SAR153191 - P3 drug product concentration 2 dose 3 Group E' SAR153191-C1F3 drug product SAR153191 - CIF3 drug product concentration 2 dose 3
- Primary Outcome Measures
Name Time Method 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 Injection site reactions include pain, erythema an edema.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Cmax At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration Maximum plasma concentration observed
Pharmacokinetics: t1/2z At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration Terminal half-life associated with the terminal slope (λz)
Pharmacokinetics: AUClast At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time
Incidence of anti-SAR153191 antibodies At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive) Pharmacokinetics: tmax At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration First time to reach Cmax
Pharmacokinetics: AUC At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration Area under the plasma concentration versus time curve extrapolated to infinity
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