Phase II Study of SR604 Subcutaneous Injection for Adults with Von Willebrand Disease Evaluating Efficacy, Safety, and Pharmacokinetics

What this Trial Is About

Researchers are evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of SR604 in adults with von Willebrand disease VWD. This Phase II trial focuses on understanding how SR604 works and its effects in treating patients diagnosed with VWD who have experienced recent bleeding episodes. Participants will receive SR604 through subcutaneous injections given as multiple doses every 4 weeks or at varying intervals of 4, 6, or 8 weeks, depending on the dose group they are assigned to. The study consists of four cohorts exploring different dosing schedules to assess treatment effects over approximately one year. Throughout the trial, participants will be closely monitored for bleeding rates, drug levels in the blood, and safety outcomes such as adverse events and antibody responses. Health status questionnaires and blood tests will be conducted regularly to evaluate treatment impact and pharmacokinetic parameters. The total participation duration is about 52 weeks, during which researchers will collect detailed data on bleeding frequency and treatment safety.

A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease