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
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.
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) ;
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