Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614907
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blinded Parallel Single-dose PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent in Healthy Chinese Adult Subjects
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is a randomized double-blinded parallel single-dose PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent in healthy Chinese adult subjects A total of 198 healthy subjects are planned to be included and randomized at a ratio of 11 to receive single 300mg20ml QL2108 injection or Dupixent
Detailed Description:
The study has a screening period of 28 days PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab thus to evaluate the similarity of the pharmacokinetics of the two study drugs
The investigator will perform safety evaluation for vital signs physical examinations ECG clinical laboratory tests and adverse events throughout the study Immunogenicity evaluation ADA ADA titration and nAb will also be evaluated
The investigator will perform safety evaluation for vital signs physical examinations ECG clinical laboratory tests and adverse events throughout the study Immunogenicity evaluation ADA ADA titration and nAb will also be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None