RecruitingPhase 1NCT07256301

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

A Multicenter, Open-Label, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Profiles of Multiple Doses of the Humanized Monoclonal Antibody EA5 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Sponsor

Shanghai Lanyi Therapeutics Co., Ltd.

Enrollment

24 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

PNH - Paroxysmal Nocturnal Hemoglobinuria

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called EA5 for people with pnh - paroxysmal nocturnal hemoglobinuria. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEA5

All treatments were given as IV infusions.

Locations(2)

The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus

Hangzhou, Zhejiang, China

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NCT07256301

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