Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05845996
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
- Detailed Description
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR441344 Keyhole limpet hemocyanin Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously placebo Keyhole limpet hemocyanin matching placebo placebo placebo matching placebo SAR441344 SAR441344 Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
- Primary Outcome Measures
Name Time Method Part 1: Number of participants with adverse event(AE) From baseline to day 127 Number of participants with AE from baseline to day 127
Part 2: Number of participants with adverse event (AE) From baseline to day 155 Number of participants with AE from baseline to day 155
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter: Cmax From Day 1 to Day 127 and to Day 155 Maximum plasma concentration (Cmax) observed
Assessment of PK parameter: AUC0-tau From day 1 to Day 155 Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)
Assessment of PK parameter: t1/2z From Day 1 to Day 127 and Day 155 Terminal half-life associated with the terminal slope (λz)
Assessment of PK parameter: AUClast From Day 1 to Day 127 Area under the plasma concentration versus time curve from time zero to the real time
Assessment of anti-KLH IgG and IgM From Day 1 to Day 127 and Day 155 Measurement of anti-KLH IgG and IgM levels in response to KLH immunization
Assessment of PK parameter: AUC Area under the plasma concentration versus time curve extrapolated to infinity From Day 1 to Day 127
Assessment of PK parameter: CL(/F) Apparent total body clearance of a drug from the plasma From Day 1 to Day 127
Assessment of PK parameter: CLss(/F) Apparent total body clearance of a drug from the plasma From day 1 to Day 155
AE attributed to KLH immunization From Day 1 to Day 127 and Day 155 Number of participants with AE attributed to KLH immunization
Assessment of PK parameter: tmax From Day 1 to Day 127 and Day 155 First time to reach Cmax (tmax)
Assessment of PK parameter: Ctrough From Day 1 to Day 155 Plasma concentration observed just before treatment administration during repeated dosing
Anti-SAR441344 antibodies From Day 1 to Day 127 and Day 155 Number of subjects with treatment emergent anti-drug antibody formation
Trial Locations
- Locations (1)
PPD-Site Number:8400001
🇺🇸Austin, Texas, United States