Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05876767
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2023-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: