Trials / Completed
CompletedNCT01101061
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Administered by subcutaneous injection |
| DRUG | Placebo | Administered by subcutaneous injection |
Timeline
- Start date
- 2010-05-03
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2010-04-09
- Last updated
- 2019-07-31
- Results posted
- 2019-07-31
Source: ClinicalTrials.gov record NCT01101061. Inclusion in this directory is not an endorsement.