Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06291948
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2023-12-04
Brief Title:
A Clinical Study With Adalimumab Biosimilar
Sponsor:
Laboratorios Richmond SACIF
Organization:
Laboratorios Richmond SACIF
Study Overview
Official Title:
A Randomized Double-blind Parallel Groups Phase 1 Clinical Study Comparing the Pharmacokinetic Safety and Immunogenicity of Adalimumab in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The study aims to evaluate the pharmacokinetic profile safety profile and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab Adalimumab Richmond Test Product vs Humira AC Pen Reference Product
Detailed Description:
This is a phase 1 pharmacokinetic safety and immunogenicity comparative single-dose double-blind randomized balanced parallel-group clinical study conducted in healthy subjects of both sexes
Blood samples are collected for up to 71 days to determine the quantification of adalimumab and for 12 months for antidrug antibody detection Safety and tolerability are also assessed
Blood samples are collected for up to 71 days to determine the quantification of adalimumab and for 12 months for antidrug antibody detection Safety and tolerability are also assessed
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None