About this trial
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera(PV).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients aged 18 years or older at the time of screening.
A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.
Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.
Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.
Disqualifiers
The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.
Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.
Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.
Uncontrolled hypertension prior to screening.
Trial design
Parallel
Treatments tested in this trial
9MW3011
DrugMultiple dose
Treatment groups
Trial outcomes
Primary outcomes
Adverse Event
Incidence of adverse events
Vital sign
Incidence of treatment-emergent clinically abnormal vital signs
Physical examination
Incidence of treatment-emergent clinically abnormal physical examinations
12-lead electrocardiogram (ECG)
Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)
Secondary outcomes
Cmax
Plasma maximum measured drug concentration
Tmax
Time of maximum concentration
AUC0-τ
Area under the plasma concentration-time curve during a dosage interval(τ)
AUC0-t
Area under the concentration-time curve from dosing to the last measurable time point
Sponsors and contacts
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