Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 7:06 PM
Study NCT ID:
NCT01059435
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: