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Clinical trial

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

NCT04621318 is registered in ClinicalTrials.gov with Samsung Bioepis Co., Ltd. as lead sponsor.

NCT NCT04621318
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Samsung Bioepis Co., Ltd.
Phase
Phase 1
Overall status
Completed
Start date
October 19, 2020
Completion date
November 9, 2022
Enrollment
168 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

healthy