Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392074
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-11
Brief Title:
A Study Investigating the Safety Absorption and Elimination of MB04 a New Compound That May Potentially Be Used in the Treatment of Autoimmune Disorders
Sponsor:
mAbxience Research SL
Organization:
mAbxience Research SL
Study Overview
Official Title:
A Randomized Double-blind Three-part Two-period Two-sequence Single-dose Cross-over Study to Compare the Pharmacokinetics PK Safety and Immunogenicity Profile of MB04 proposed Etanercept Biosimilar EU-sourced Enbrel and US Licensed Enbrel in Healthy Male Volunteers
Status:
ACTIVE_NOT_RECRUITING
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:
MB04-A-01-23
Brief Summary:
This is a randomized double-blind three-part two-sequence per part two-period single-dose cross-over study in healthy male volunteers to compare the PK safety and immunogenicity of MB04 and EU US Enbrel
During the course of the study the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood and by comparing these levels among the different administration arms Safety tolerability and immunologic response to the administered drugs will also be evaluated throughout
During the course of the study the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood and by comparing these levels among the different administration arms Safety tolerability and immunologic response to the administered drugs will also be evaluated throughout
Detailed Description:
The primary objective of the study is to demonstrate PK similarity between MB04 and EU-Enbrel between MB04 and US Enbrel as well as between EU-Enbrel and US-Enbrel Additional PK parameters will be evaluated as secondary endpoints
Safety and tolerability will be assessed through Adverse Events clinical laboratory vital signs ECGs and physical examination findings and any other parameter that is relevant for safety assessment
The incidence of ADA to etanercept and the neutralizing potential and titre of positive ADA will be reported
Safety and tolerability will be assessed through Adverse Events clinical laboratory vital signs ECGs and physical examination findings and any other parameter that is relevant for safety assessment
The incidence of ADA to etanercept and the neutralizing potential and titre of positive ADA will be reported
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