drugset / Trial / NCT07256301

A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT07256301 ↗

Phase 1 Recruiting 24 enrolled Shanghai Lanyi Therapeutics Co., Ltd.
RandomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Timeline

Start
2024-01-03
Primary completion
2026-08-31
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject EA5 Monoclonal antibody 900 mg Intravenous
Subject EA5 Monoclonal antibody 1200 mg Intravenous
Subject EA5 Monoclonal antibody 1400 mg Intravenous