This is a Phase Ib, open-label, dose-escalation, single-center/multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of multiple doses of EA5 (a humanized anti-complement C5 monoclonal antibody) in adult participants with anti-AChR antibody-positive generalized myasthenia gravis (gMG) who have not previously received complement inhibitor therapy. Approximately 18 participants will be enrolled. The study consists of a screening period (Day -42 to Day -1), a loading period (Day 1 to Day 14), a treatment observation period (Day 15/Week 3 to Day 99/Week 15), and an end-of-study visit (up to Day 155/Week 23). All participants receive a loading does , then are assigned to one of three maintenance dose cohorts: Cohort 1 (Low Dose), Cohort 2 (MID Dose), and Cohort 3 (High Dose). The primary objective is to assess safety and tolerability. Secondary objectives include preliminary efficacy, PK, PD (complement inhibition), and immunogenicity.
Male or female aged ≥18 years.
positive serology for anti-acetylcholine receptor (AChR) antibody at screening; and
any one of the following: abnormal neuromuscular transmission confirmed by repetitive nerve stimulation; history of positive anticholinesterase test (e.g., neostigmine test); or improvement in MG signs after oral cholinesterase inhibitors as assessed by the treating physician.
Body weight between 40 kg and 100 kg (inclusive) at screening.
Presence of untreated thymic epithelial tumors (including all types of thymoma or thymic carcinoma), extrathymic germ cell tumor, or other malignant mediastinal masses at the screening visit; or, as judged by the investigator, presence of thymic cysts or other space-occupying lesions requiring immediate intervention.
History of thymectomy or any other thymic surgery within 12 months prior to screening, or planned thymectomy during the trial period.
Curative treatment (e.g., R0 surgical resection) completed ≥ 12 months prior to the screening visit;
No clinical evidence of recurrence within 12 months prior to screening;
Single group
EA5
DrugFirst, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
EA5
DrugFirst, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
EA5
DrugFirst, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W).
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Change and percentage change from baseline in MG-ADL total score.
The proportion of participants who achieve the Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) response , along with the 2-sided 95% CI
Change and percentage change from baseline in QMG total score.
The mean change of quantitative myasthenia gravis (QMG) total score，along with 2-sided 95% CI
Change and percentage change from baseline in MGC total score.
The mean change of myasthenia gravis composite (MGC) total score, along with 2-sided 95% CI
Change and percentage change from baseline in MG-QoL15r scale.
The mean change of revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL 15r scale), along with 2-sided 95% CI
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