A Phase 1b Study Evaluating Safety and Immune Response of 9MW3011 Infusions in Adults with Polycythemia Vera

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the drug 9MW3011 in Chinese patients diagnosed with Polycythemia Vera PV. This phase 1b clinical trial aims to understand how the drug behaves in the body and its effects in patients who have shown resistance or intolerance to existing treatments like hydroxyurea or Interferon alpha. Participants will be assigned to one of three dose groups, each containing 8 patients. All subjects will receive multiple doses of 9MW3011 through intravenous infusion. Decisions about increasing the dose or expanding the number of participants will depend on the safety and pharmacokineticpharmacodynamic data collected during the study. Throughout the study, participants will undergo various assessments including monitoring for adverse events, vital signs, physical exams, ECGs, and laboratory tests up to 141 or 197 days. Researchers will also measure drug concentration levels and immune responses, as well as symptom scores related to PV. The trial will carefully track safety and drug effects over this period to inform further development.

A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera