Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05876767
Brief 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.
Detailed 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:
NCT05876767
Study Brief:
Protocol Section:
NCT05876767