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To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT2606 Injection | Experimental | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
|
| Mepolizumab Injection (EU-licensed Nucala®) | Active Comparator | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
|
| Mepolizumab Injection (US-licensed Nucala®) | Active Comparator | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab Injection (BAT2606 Injection) | Drug | In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum blood concentration | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| AUC0-∞ | Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive).
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, PhD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40786037 | Derived | Li C, Sun J, Xu J, Wu M, Li X, Liu Z, Dong Q, Sun Y, Ding Y. Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial. Front Pharmacol. 2025 Jul 25;16:1580883. doi: 10.3389/fphar.2025.1580883. eCollection 2025. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
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double-blinded design.
|
| Mepolizumab Injection (EU-licensed Nucala) | Drug | In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®). |
|
|
| Mepolizumab Injection (US-licensed Nucala) | Drug | In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®). |
|
|
Observed time to peak concentration
| Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| t1/2 | Elimination half-life t1/2 = 0.693/λz | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| CL/F | Total clearance rate, CL/F=Dose/AUC0-∞ | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| Vd | Apparent volume of distribution, Vd =Dose/(AUC0-∞ × λz) | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| λz | Terminal elimination rate constant. The negative of the slope value obtained by taking the logarithm of the drug concentration and performing a linear regression against time is the terminal elimination rate constant | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| Adverse events | AE and SAE | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| Immunogenicity | Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA. | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |