Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976386
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2023-07-28
Brief Title:
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open-label Parallel Design Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2023-07-09
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 is a parallel group treatment Phase 1 open-label 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous SC single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years
The estimated duration is up to 21 days of screening period followed by the treatment day with a follow-up treatment period of 42 days until the end of study EOS visit Total duration from screening to EOS will be 64 days maximum
The estimated duration is up to 21 days of screening period followed by the treatment day with a follow-up treatment period of 42 days until the end of study EOS visit Total duration from screening to EOS will be 64 days maximum
Detailed Description:
Duration per participant is up to 64 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1266-7002 | REGISTRY | ICTRP | None |