Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310824
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-29
Brief Title:
Single Dose Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia
Sponsor:
Xentria Inc
Organization:
Xentria Inc
Study Overview
Official Title:
A Randomized Double-blind Controlled Parallel-group Single Dose Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia Sourced From the European Union and United States in Healthy Male Participants
Status:
RECRUITING
Status Verified Date:
2024-06
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:
A Randomized Double-blind Controlled Parallel-group Single Dose Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia
Detailed Description:
This study is a Phase 1 double-blind randomized single dose parallel-group 3-arm Pharmacokinetic PK study designed to assess the biosimilarity including the PK Pharmacodynamics PD safety tolerability and immunogenicity of MAB-22 compared with reference Prolia sourced from the European Union EU and United States US after single subcutaneous SC injection in healthy male participants
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