Rheumatoid Arthritis
Conditions
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
Interventions
DRUGSAR153191-P3 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
DRUGSAR153191-P2 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
DRUGSAR153191-C1F3 drug product
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 |
| 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 |
| 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 |
| 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) | — |
| 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) |
Outcome results
None listed