Phase 1Completed
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
- Sponsor
- Samsung Bioepis Co., Ltd. (Industry)
- Enrolment
- 168 enrolled
- Conditions
- Healthy
- Interventions
- Denosumab
- Ages
- adults
- Registry
- NCT04621318
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- AUCinf
- AUClast
- Cmax
History
Last registry update
Primary completion
Registered
Started