Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
The multiple dose fo the starting dose cohorts will comprise 3 dose cohorts of 8 PV subjects each.In each cohort, subjects will receive 9MW3011 via intravenous infusion.A decision on whether to proceed with case expansion and dose escalation will be based on the safety and PK-PD data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Open-label 9MW3011 Dose1 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
|
| Experimental: Open-label 9MW3011 Dose2 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
|
| Experimental: Open-label 9MW3011 Dose3 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW3011 | Drug | Multiple dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Incidence of adverse events | Up to 141 or 197 days |
| Vital sign | Incidence of treatment-emergent clinically abnormal vital signs | Up to 141 or 197 days |
| Physical examination | Incidence of treatment-emergent clinically abnormal physical examinations | Up to 141 or 197 days |
| 12-lead electrocardiogram (ECG) | Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs) | Up to 141 or 197 days |
| Laboratory test result | Incidence of treatment-emergent clinically significant laboratory test results | Up to 141 or 197 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Plasma maximum measured drug concentration | Day 1 to Day 141 or 197 |
| Tmax | Time of maximum concentration | Day 1 to Day 141 or 197 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AUC0-τ | Area under the plasma concentration-time curve during a dosage interval(τ) | Day 1 to Day 141 or 197 |
| AUC0-t | Area under the concentration-time curve from dosing to the last measurable time point | Day 1 to Day 141 or 197 |
| AUC0-∞ | Area under the concentration-time curve from dosing to infinity | Day 1 to Day 141 or 197 |
| λz | Terminal elimination rate constant | Day 1 to Day 141 or 197 |
| t1/2z | The terminal elimination half-life | Day 1 to Day 141 or 197 |
| MRT | Mean residence time | Day 1 to Day 141 or 197 |
| Vss | Volume of Distribution at Steady State | Day 1 to Day 141 or 197 |
| CLss | Steady-state clearance | Day 1 to Day 141 or 197 |
| DF | Fluctuation percentage | Day 1 to Day 141 or 197 |
| Ctrough | Trough Concentration | Day 1 to Day 141 or 197 |
| Rac(AUC) | Accumulation ratio calculated from the AUCτ,ss and AUCτ after single dosing | Day 1 to Day 141 or 197 |
| Rac(cmax) | Accumulation ratio calculated from the Cmax,ss and Cmax after single dosing | Day 1 to Day 141 or 197 |
| Hepcidin | Change from baseline in hepcidin levels | Day 1 to Day 141 or 197 |
| Serum iron | Change from baseline in serum iron levels | Day 1 to Day 141 or 197 |
| Transferrin saturation (TSAT) | Change from baseline in transferrin saturation (TSAT) levels | Day 1 to Day 141 or 197 |
| Anti-drug antibodies(ADA) | The incidence of ADA | Day 1 to Day 141 or 197 |
| Hematocrit (HCT) | Change from baseline in HCT levels | Day1 to Day 141 or 197 |
| Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score(MPN-SAF TSS) | Change from baseline in MPN-SAF TSS score | Day 1 to Day 141 or 197 |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Tianjin | Tianjin Municipality | China |
|
| The Second Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
Not provided
Not provided