The purpose of this study is to evaluate the safety, tolerability, immunogenicity , PK, and PD of a single dose of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors （Part A）and to evaluate the safety, PK, PD, and efficacy of multiple doses of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B and Part C).
Age ≥18 years and ≤65 years at the time of signing informed consent, regardless of sex;
Hemophilia A or B patients with historical or screening FVIII activity level <1% or FIX activity level ≤2%; Note: Hemophilia A or B patients with or without inhibitors may be enrolled. For patients without inhibitors (inhibitor titer <0.6 BU/mL), they must have previously received coagulation factor treatment with exposure days (EDs) >50 days.
Congenital coagulation Factor VII deficiency patients with historical or screening FVII activity <10%;
Part A only: Received on-demand treatment with FVIII, FIX, recombinant human coagulation Factor VIIa (rFVIIa), or PCC for bleeding events within 1 month prior to screening;
Subjects with a known history of hypersensitivity to the investigational medicinal product or any of its components;
Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect administration and safety assessment;
Hemoglobin <60 g/L;
Platelet count <100 × 10^9/L;
Parallel
SR604
DrugSR604 will be administered as SC injection
SR604
DrugSR604 will be administered as SC injection.
SR604
DrugSR604 will be administered as SC injection.
Part A: Incidence of AEs/SAEs/AESI
Assessed through clinical signs and symptoms, vital signs, physical examination, laboratory tests (complete blood count, urinalysis, and blood biochemistry), coagulation function \[PT, TT, INR, FIB, APTT, D-dimer\], FDP, 12-lead electrocardiogram, injection site reactions, hypersensitivity/allergic reactions, thrombotic events, etc.;Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
PartA: Incidence of drug-related AEs/SAEs/AESIs
Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Part A: Number and incidence of patients with anti-drug antibodies (ADA) and neutralizing antibodies
Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Part B/ Part C:Treated total annualized bleeding rate (ABR)
Part A:Single-dose pharmacokinetic (PK) parameters:Peak Plasma Concentration (Cmax)
PK of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Part B/ Part C:Treated spontaneous annualized bleeding rate
Part B/ Part C:Treated total annualized joint bleeding rate
Part B/ Part C:Treated annualized menorrhagia bleeding rate (applicable only to reproductive-age female patients with congenital FVII deficiency and active menstruation)
Part A, part B and part C: Pharmacodynamic parameters-protein C
Part A, part B and part C: Pharmacodynamic parameters-prothrombin time (PT)
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