Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 6:06 PM
Study NCT ID:
NCT06310824
Status:
None
Last Update Posted:
2025-07-29 00:00:00
First Post:
2024-02-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
Sponsor:
None
Organization:
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:
None
Status Verified Date:
2025-07
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 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.
Detailed Description:
None
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?: