Trial Profile
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
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 31 Jul 2023
Price :
$35
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At a glance
- Drugs Eculizumab (Primary)
- Indications Paroxysmal nocturnal haemoglobinuria
- Focus Pharmacokinetics
- Sponsors Samsung Bioepis
- 15 Jun 2023 Results assessing Population Pharmacokinetic/Pharmacodynamic/Efficacy Modeling of Sb12 (Proposed Eculizumab Biosimilar) and Reference Eculizumab presented at the 28th Congress of the European Haematology Association
- 29 Mar 2022 Results published in the International Journal of Clinical Pharmacology and Therapeutics
- 14 Dec 2021 Results presented at the 63rd American Society of Hematology Annual Meeting and Exposition