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.
Sequential
EA5
Biological/VaccineAll treatments were given as IV infusions.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Maximum Observed Serum Concentration (Cmax) of EA5
Blood samples were collected for analysis of Cmax
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Blood samples were collected for analysis of Tmax
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Blood samples were collected for analysis of AUC0-t
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Blood samples were collected for analysis of AUCinf
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