Primary objective * The tolerability and safety of SAR443809 Secondary * The PK parameters of SAR443809 * The PD activity of SAR443809 * The immunogenicity of SAR443809
Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Parexel International Site Number : 8400002
Glendale, California, United States
Parexel International Site Number : 8400003
Baltimore, Maryland, United States
Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Time frame: Baseline up to 23 weeks
Incidence of potentially Clinical laboratory abnormalities
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL)
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Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)
Time frame: Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)
Time frame: Baseline up to 23 weeks
Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50])
Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Alternative Pathway kit and a hemolytic assay (AH50)
Time frame: Baseline up to 23 weeks
Complement classical pathway activity (Wieslab CP)
Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Classical Pathway kit
Time frame: Baseline up to 23 weeks
Incidence of treatment -emergent Anti-SAR443809 antibodies
Time frame: Baseline up to 23 weeks