Clinical Research Directory

Inclusion Criteria: * Voluntarily participate in this clinical study, understand and follow study procedures and voluntarily sign the ICF; * Body mass index (BMI) ≥ 18.0 kg/m2 , male or female, ≥ 18 years of age (including the critical value) at the time of signing the ICF; * Confirmed diagnosis of PNH by clinical presentation and flow cytometry; flow cytometry within 6 months prior to or during screening consistent with granulocyte clonal size ≥ 10%; * Hb \< 100 g/L； * Lactate dehydrogenase (LDH) \> 1.5 × ULN； * Subject is willing to receive 4-valent meningococcal vaccine, Streptococcus pneumoniae vaccine at least 14 days prior to dosing. If 4-valent meningococcal vaccine is administered within 3 years before the first dose, it may not be repeated; if S. pneumoniae vaccine is administered within 5 years, it may not be repeated; * Agreed to use a highly effective method of contraception throughout the study and for 12 months after the last study dose. Exclusion Criteria: * History of hypersensitivity to VSA012 or its excipients; * Use of any complement inhibitor within 3 months before screening or within 5 half-lives (whichever is longer); * Infections prior to first dose; * Prior splenectomy; * Previously suspected/confirmed hereditary complement deficiency; * History of recurrent invasive infection with encapsulated bacteria such as meningococcus or pneumococcus; * Severe aplastic anemia (SAA) at screening and receiving immunosuppressive therapy; * Patients with previous autoimmune diseases requiring systemic treatment, such as human immunodeficiency virus (HIV) infection, except for corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency; * History of allogeneic transplantation, stem cell transplantation, organ transplantation or other transplant.