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Clinical trial

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects

NCT03722329 is registered in ClinicalTrials.gov with Samsung Bioepis Co., Ltd. as lead sponsor.

NCT NCT03722329
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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, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
Lead sponsor
Samsung Bioepis Co., Ltd.
Phase
Phase 1
Overall status
Completed
Start date
November 13, 2018
Completion date
April 8, 2019
Enrollment
240 (actual)
Sites
1

Conditions

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

healthy