A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Keyhole limpet hemocyanin
- Conditions
- Healthy Volunteers
- Sponsor
- Sanofi
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Part 1: Number of participants with adverse event(AE)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
placebo
matching placebo
Intervention: Keyhole limpet hemocyanin
SAR441344
Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
Intervention: SAR441344
SAR441344
Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
Intervention: Keyhole limpet hemocyanin
placebo
matching placebo
Intervention: placebo
Outcomes
Primary Outcomes
Part 1: Number of participants with adverse event(AE)
Time Frame: From baseline to day 127
Number of participants with AE from baseline to day 127
Part 2: Number of participants with adverse event (AE)
Time Frame: From baseline to day 155
Number of participants with AE from baseline to day 155
Secondary Outcomes
- Assessment of PK parameter: Cmax(From Day 1 to Day 127 and to Day 155)
- Assessment of PK parameter: AUC0-tau(From day 1 to Day 155)
- Assessment of PK parameter: t1/2z(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: AUClast(From Day 1 to Day 127)
- Assessment of anti-KLH IgG and IgM(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: AUC(Area under the plasma concentration versus time curve extrapolated to infinity)
- Assessment of PK parameter: CL(/F)(Apparent total body clearance of a drug from the plasma)
- Assessment of PK parameter: CLss(/F)(Apparent total body clearance of a drug from the plasma)
- AE attributed to KLH immunization(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: tmax(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: Ctrough(From Day 1 to Day 155)
- Anti-SAR441344 antibodies(From Day 1 to Day 127 and Day 155)