drugset
drugset / Trial / NCT03722329

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

NCT03722329 ↗

Phase 1 Completed 240 enrolled Samsung Bioepis Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

Summary

This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.

Timeline

Start
2018-11-13
Primary completion
2019-03-29
Completion
2019-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 300 mg —

Indications

No indication recorded.