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Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants

Healthy Volunteer Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Subcutaneous Doses of SAR444336 in Healthy Adult Participants

Clinical Trial Summary

This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal product (IMP) to patients.

Clinical Trial Description

The anticipated study duration per participant is up to 10 weeks in Part 1. - Screening: 2 to 28 days prior to dosing (Day -28 to Day -2) - Treatment period: Day -1 to Day 29 post dose including - Institutionalization: Day -1 until Day 8 - Ambulant period including repeat PK and PD blood sampling and ambulant visits: Day 9 to Day 29 - Follow-up period: Day 30 to Day 43 The anticipated study duration per participant is up to 17 weeks in Part 2. - Screening: 2 to 28 days prior to dosing (Day -28 to Day -2) - Treatment period: Day -1 to Day 57 (Q2W/3 doses or Q4W/2 doses) or Day -1 to Day 85 (Q4W/3 doses), or Day -1 to Day 50 (Q3W) including - Institutionalization: Day -1 until Day 3 - Ambulant period including repeat PK and PD blood sampling, ambulant visits and 24 hours institutionalization after 2nd and/or 3rd dose: Day 4 to Day 57 (Q2W/3 doses, Q4W/2 doses), Day 4 to Day 85 (Q4W/3 doses) or Day 50 (Q3W) - Follow-up period: Day 58 to Day 71 (Q2W/3 doses or Q4W/2 doses), Day 71 to Day 85 (Q4W/3 doses) or Day 51 to Day 64 (Q3W) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05876767
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date October 15, 2021
Completion date December 12, 2023
View Details
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