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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 9MW3011

    Drug

    Multiple dose

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Experimental: Open-label 9MW3011 Dose1Experimental treatment 1 intervention
Group B: Experimental: Open-label 9MW3011 Dose2Experimental treatment 1 intervention
Group C: Experimental: Open-label 9MW3011 Dose3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Event

Incidence of adverse events

Time frame
Up to 141 or 197 days
2

Vital sign

Incidence of treatment-emergent clinically abnormal vital signs

Time frame
Up to 141 or 197 days
3

Physical examination

Incidence of treatment-emergent clinically abnormal physical examinations

Time frame
Up to 141 or 197 days
4

12-lead electrocardiogram (ECG)

Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)

Time frame
Up to 141 or 197 days

Secondary outcomes

1

Cmax

Plasma maximum measured drug concentration

Time frame
Day 1 to Day 141 or 197
2

Tmax

Time of maximum concentration

Time frame
Day 1 to Day 141 or 197
3

AUC0-τ

Area under the plasma concentration-time curve during a dosage interval(τ)

Time frame
Day 1 to Day 141 or 197
4

AUC0-t

Area under the concentration-time curve from dosing to the last measurable time point

Time frame
Day 1 to Day 141 or 197

Other outcomes

Sponsors and contacts

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