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drugset / Trial / NCT05539248

A Study on the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 in Subjects With PNH

NCT05539248 ↗

Phase 1/2 Unknown 78 enrolled CARE Pharma Shanghai Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of the study is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of CAN106 administered intravenously to subjects with PNH who have not previously been treated with a complement inhibitor.

Timeline

Start
2022-03-25
Primary completion
2024-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject OMOPRUBART Monoclonal antibody 20 mg/kg Intravenous
Subject OMOPRUBART Monoclonal antibody 40 mg/kg Intravenous
Subject OMOPRUBART Monoclonal antibody 80 mg/kg Intravenous

Indications

paroxysmal nocturnal hemoglobinuria