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).
Male or female subjects aged ≥18 years.
Body weight between 40 kg and 100 kg (inclusive) at screening.
a) Previously naive to complement inhibitor therapy; or
b) Previously treated with a complement inhibitor, which has been discontinued for ≥5 half-lives prior to screening.
History of allogeneic bone marrow transplantation.
History of Neisseria meningitidisinfection within 6 months prior to screening and before the first dose.
Known or suspected immunodeficiency (e.g., history of frequent or recurrent infections).
Known or suspected hereditary complement deficiency.