Evaluation of SR604 Injection for Safety, Tolerability, and Effectiveness in Adults with Hemophilia A, Hemophilia B, or Factor VII Deficiency

What this Trial Is About

Researchers are evaluating SR604, a drug administered by subcutaneous injection, in adults aged 18 to 65 with Hemophilia A, Hemophilia B, or congenital Factor VII deficiency. This Phase III trial aims to assess the safety, tolerability, immune response, pharmacokinetics, pharmacodynamics, and effectiveness of both single and multiple doses of SR604 in participants with or without inhibitors to clotting factors. The study has three parts Part A tests single doses of SR604 in participants with Hemophilia A or B across six dose levels. Parts B and C study multiple doses of SR604 given every 2 weeks or at intervals of 4, 6, or 8 weeks in participants with Hemophilia A, Hemophilia B, or Factor VII deficiency. These are designed to explore the drugs safety, behavior in the body, and ability to reduce bleeding episodes. Participants will be involved in dosing and monitoring visits lasting up to about 85 days for Part A, 211 days for Part B, and 393 days for Part C. Assessments include safety monitoring, blood tests for drug levels and immune response, bleeding rates, joint health scoring, and quality of life questionnaires. The research team will track adverse events, antibody development, and treatment effects over time to evaluate SR604s profile in these bleeding disorders.

An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII Deficiency