Trials / Completed
CompletedNCT04621318
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Male
- Age
- 28 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab | 60 mg, single-dose |
Timeline
- Start date
- 2020-10-19
- Primary completion
- 2022-11-09
- Completion
- 2022-11-09
- First posted
- 2020-11-09
- Last updated
- 2022-11-28
Locations
2 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04621318. Inclusion in this directory is not an endorsement.