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

Recruiting Phase 1 Interventional Study
PNH - Paroxysmal Nocturnal Hemoglobinuria
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Shanghai Lanyi Therapeutics Co., Ltd. · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female subjects aged ≥18 years. * Body weight between 40 kg and 100 kg (inclusive) at screening. * Patients diagnosed with PNH, confirmed by flow cytometry demonstrating a PNH clone size (glycosylphosphatidylinositol-anchored protein-deficient granulocytes or monocytes…
Contacts

Fengkui zhang, Dr.

+86-022-23909999

zhfk@hotmail.com

CONTACT