Trials / Completed
CompletedNCT01825785
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women With Low Bone Mass
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Administered by subcutaneous injection |
| DRUG | Placebo | Administered by subcutaneous injection |
Timeline
- Start date
- 2007-11-14
- Primary completion
- 2008-12-02
- Completion
- 2008-12-02
- First posted
- 2013-04-08
- Last updated
- 2023-08-30
- Results posted
- 2019-07-05
Source: ClinicalTrials.gov record NCT01825785. Inclusion in this directory is not an endorsement.