Trials / Completed
CompletedNCT01059435
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 45 Years – 59 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Administered subcutaneously or intravenously |
| DRUG | Placebo | Administered subcutaneously or intravenously |
Timeline
- Start date
- 2006-12-13
- Primary completion
- 2007-07-06
- Completion
- 2007-07-06
- First posted
- 2010-02-01
- Last updated
- 2019-07-05
- Results posted
- 2019-07-05
Source: ClinicalTrials.gov record NCT01059435. Inclusion in this directory is not an endorsement.