Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Study Overview
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Brief Summary
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Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SAR441344
* Drug: placebo
* Biological: Keyhole limpet hemocyanin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - Having given written informed consent prior to undertaking any study-related procedure. Exclusion criteria - 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR441344<br>Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously | Drug: SAR441344<br>* Solution for intravenous/subcutaneous injection<br>Biological: Keyhole limpet hemocyanin<br>* Subcutaneous Lyophilized powder for reconstitution<br>|
| Placebo Comparator: placebo<br>matching placebo | Drug: placebo<br>* Solution for intravenous/subcutaneous injection<br>Biological: Keyhole limpet hemocyanin<br>* Subcutaneous Lyophilized powder for reconstitution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Number of participants with adverse event(AE) | Number of participants with AE from baseline to day 127 | From baseline to day 127 | 
| Part 2: Number of participants with adverse event (AE) | Number of participants with AE from baseline to day 155 | From baseline to day 155 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of PK parameter: Cmax | Maximum plasma concentration (Cmax) observed | From Day 1 to Day 127 and to Day 155 | 
| Assessment of PK parameter: tmax | First time to reach Cmax (tmax) | From Day 1 to Day 127 and Day 155 | 
| Assessment of PK parameter: AUClast | Area under the plasma concentration versus time curve from time zero to the real time | From Day 1 to Day 127 | 
| Assessment of PK parameter: AUC | From Day 1 to Day 127 | Area under the plasma concentration versus time curve extrapolated to infinity | 
| Assessment of PK parameter: AUC0-tau | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours) | From day 1 to Day 155 | 
| Assessment of PK parameter: Ctrough | Plasma concentration observed just before treatment administration during repeated dosing | From Day 1 to Day 155 | 
| Assessment of PK parameter: t1/2z | Terminal half-life associated with the terminal slope (λz) | From Day 1 to Day 127 and Day 155 | 
| Assessment of PK parameter: CL(/F) | From Day 1 to Day 127 | Apparent total body clearance of a drug from the plasma | 
| Assessment of PK parameter: CLss(/F) | From day 1 to Day 155 | Apparent total body clearance of a drug from the plasma | 
| Anti-SAR441344 antibodies | Number of subjects with treatment emergent anti-drug antibody formation | From Day 1 to Day 127 and Day 155 | 
| Assessment of anti-KLH IgG and IgM | Measurement of anti-KLH IgG and IgM levels in response to KLH immunization | From Day 1 to Day 127 and Day 155 | 
| AE attributed to KLH immunization | Number of participants with AE attributed to KLH immunization | From Day 1 to Day 127 and Day 155 |