Phase 1 Evaluation of SR604 Safety and Effects in Adults with Hemophilia A, Hemophilia B, or Factor VII Deficiency and Healthy Volunteers

What this Trial Is About

Researchers are studying SR604, a new drug, to understand its safety, how the body processes it, and its effects in both healthy adults and adults with bleeding disorders such as Hemophilia A, Hemophilia B, or Factor VII deficiency. The study includes healthy volunteers in Part A and patients with these bleeding disorders, some of whom may have inhibitors, in Part B. This first-in-human trial aims to gather important information about SR604s safety and effectiveness. In Part A, healthy participants receive a single subcutaneous injection of SR604 or a placebo in escalating doses across several groups. Part B involves participants with bleeding disorders receiving multiple subcutaneous injections of SR604 every four weeks at increasing dose levels. Both parts involve randomized assignment to treatment or placebo groups, with Part A focusing on single doses and Part B on multiple doses over time. Participants will be monitored for approximately three months, with assessments including medical exams, blood tests, and safety evaluations. Researchers will track adverse events, changes in blood clotting markers, drug concentration levels, bleeding events, and the presence of antibodies against the drug. This monitoring helps understand the drugs effects and safety profile throughout the study period.

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)