Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326814
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-05
Brief Title:
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A First-in-human Randomized Double-blind Placebo-controlled Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-03
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
The tolerability and safety of SAR443809 Secondary
The PK parameters of SAR443809
The PD activity of SAR443809
The immunogenicity of SAR443809
The tolerability and safety of SAR443809 Secondary
The PK parameters of SAR443809
The PD activity of SAR443809
The immunogenicity of SAR443809
Detailed Description:
Screening up to 56 days Day -56 to Day -2 Treatment 1 day treatment on Day 1 study observation period from Day -1 to Day 3 Follow-up and end of study 105 days after IMP administration follow up visits from Day 5 to Day 78 End of study visit on Day 106 Total study duration for each participant approximately 23 weeks
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 |
|---|---|---|---|
| U1111-1298-7281 | REGISTRY | ICTRP | None |