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The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers.
The plan is to enroll 88 healthy subjects. After signing the written informed consent voluntarily, the subjects will undergo a series of examinations and information collection to determine whether they meet the inclusion criteria. The qualified subjects will be randomized and administered. Biological samples were collected and safety checked before and after administration according to protocol requirements. Adverse events occurred during the trial were collected, and the combination of drug use and non-drug treatment were asked and recorded in detail.
When the 90% confidence interval of geometric mean ratio of the main pharmacokinetic parameters of Meperizumab injection and NUCALA® was within the range of 80.00%-125.00%, it was proved that the pharmacokinetic characteristics of the two were similar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meperizumab injection | Experimental | Subcutaneous injection of meperizumab once |
|
| NUCALA® | Active Comparator | Subcutaneous injection of NUCALA® once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meperizumab injection | Drug | Meperizumab injection is a humanized monoclonal antibody of IgG1 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration(Cmax) | Peak maximum plasma drug concentration | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Area under drug concentration - time curve(AUC0-t) | Area under the curve from zero to the lowest detectable blood drug concentration | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve extrapolating from zero to infinity(AUC0-∞) | Area under the curve from zero to infinity | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Peak concentration time(Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haimiao Yang, Master | Contact | 0431-86177635 | czfyyq728@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D014890 | Granulomatosis with Polyangiitis |
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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| NUCALA® | Drug | NUCALA® is a humanized monoclonal antibody of IgG1 injection |
|
Time to reach maximum plasma concentration after dosing |
| 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| half-life(T1/2) | The time it takes for serum drug concentrations to drop by half | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Elimination rate constant(λz) | The slope of the terminal segment of a semi-logarithmic curve | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Residual area percentage(AUC%Extrap) | The percentage of the difference between AUC0-∞ and AUC0-t as a percentage of AUC0-t | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Apparent clearance(CL/F) | Percentage of the body that eliminates organ-scavenging drugs | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Apparent volume of distribution(Vd/F) | Apparent volume of distribution after non-intravenous administration | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Physical examination | The doctor will percuss, look, and question the subject, and record any abnormalities in the skin, spine, or limbs | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Body temperature | Abnormal body temperature | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Pulse | Abnormal pulse | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Blood pressure | Abnormal blood pressure | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Electrocardiogram(ECG) QT Interval | Abnormal ECG QT Interval | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Anti-drug antibody(ADA) | ADA positive | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| Neutralizing antibody(NAb) | NAb positive | 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |