This is an open-label, multicenter, exploratory Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of SR604 Injection in patients with congenital coagulation Factor VII deficiency.
Age ≥12 years and ≤65 years at the time of signing the informed consent form; both genders eligible;
Clinically diagnosed with congenital coagulation Factor VII deficiency, with historical or screening FVII activity <10%, and ≥2 treated new-onset bleeding events within 3 months prior to enrollment;
No active bleeding symptoms prior to first administration of SR604 Injection;
The subject and/or legal representative and impartial witness have signed the informed consent form, indicating voluntary agreement to participate in this trial, to provide biological samples for testing as required by the protocol, and to comply with the planned study visits;
Known history of hypersensitivity to the study drug formulation or any of its components;
Intolerance to subcutaneous injection or other local skin abnormalities or dermatoses that may affect drug administration or safety assessment;
Hemoglobin <60 g/L;
Platelet count <100×10⁹/L;