Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159452
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2023-11-28
Brief Title:
Study of the Tolerability of Different SAR153191 Drug Products That Differ With Respect to Manufacturing Processes and Formulation at Different Concentrations and Doses in Healthy Male Subjects
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Double-blind Single Subcutaneous Dose Parallel Design Study of the Tolerability of Different SAR153191 Drug Products That Differ With Respect to Manufacturing Processes and Formulation at Different Concentrations and Doses in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Primary objective
To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation at different concentrations and doses after administration of single subcutaneous doses to healthy male subjects
Secondary objectives
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously
To assess the safety of the different SAR153191 drug products administered subcutaneously
To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation at different concentrations and doses after administration of single subcutaneous doses to healthy male subjects
Secondary objectives
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously
To assess the safety of the different SAR153191 drug products administered subcutaneously
Detailed Description:
Up to 35 Days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1293-6227 | REGISTRY | ICTRP | None |