Severe Asthma
Conditions
Brief summary
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
Detailed description
This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.
Interventions
DRUGMepolizumab Injection (BAT2606 Injection)
In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.
DRUGMepolizumab Injection (EU-licensed Nucala)
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).
DRUGMepolizumab Injection (US-licensed Nucala)
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blinded design.
Intervention model description
It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Subjects have signed the informed consent before the trial, and fully understood the content, process and relevant risks of the trial. * 2\. Subjects who are able to complete the study in accordance with the requirements of the protocol. * 3\. Visiting subjects (including partners) who are willing to comply with the study provisions agree to have no pregnancy plans and no donor sperm plans throughout the trial and for 6 months after dosing, and to voluntarily use effective contraception, as described in Appendix 4. * 4\. Subjects with BMI between 18 and 28 kg/m2 (both inclusive) and body weight between 55 and 85 kg (both inclusive). * 5\. Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive). * 6\. Subjects with normal or abnormal physical examinations without clinical significance.
Exclusion criteria
* 1\. Subjects who have clinically significant abnormalities in clinical laboratory tests. * 2\. Subjects with clinical significance of abnormal ECG, chest x-ray. * 3\. Subjects with history of hypertension. * 4\. Subject who are or had been suffering from malignant neoplasm; subject who are or had been suffering from inflammatory bowel disease. * 5\. Subjects who have an active infection within 2 months prior to screening, including acute and chronic infections as well as localized infections. * 6\. Subjects who have active tuberculosis. * 7\. Subjects who have been exposed to TB within 3 months prior to screening. * 8\. Subjects whose T-cell test for tuberculosis infection (T-SPOT.TB) results are positive. * 9\. Subjects who are positive for HBsAg on the hepatitis B half test. * 10\. Subjects who have had a major injury or undergone previous surgical procedures or fracture within 4 weeks prior to enrollment. * 11\. Subjects who have taken any prescription medication within 28 days prior to screening. * 12\. Subjects who participate in another drug clinical trial within 3 months prior to enrollment. * 13\. Subjects who suffered an acute illness from the screening period until study drug administration. * 14\. Subjects who have received Mepolizumab (or its biosimilar) within 6 months (or within 5 half-lives of the drug, whichever is longer) prior to screening. * 15\. Subjects who have received live vaccination during the study period within 12 weeks prior to study dosing. * 16\. Subjects who are suspected or confirmed to be allergic (allergic to multiple medications or foods). * 17\. Subjects who smoked more than 5 cigarettes per day in the 3 months prior to screening. * 18\. Subjects who have taken any alcohol-containing product within 24h prior to study dosing. * 19\. Subjects who have donated blood or lost a significant amount of blood (\> 450 mL) within 3 months prior to study drug administration. * 20\. Subjects with a positive urine drug screening. * 21\. Subject who is deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Maximum blood concentration |
| AUC0-∞ | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Elimination half-life t1/2 = 0.693/λz |
| CL/F | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Total clearance rate, CL/F=Dose/AUC0-∞ |
| Vd | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Apparent volume of distribution, Vd =Dose/(AUC0-∞ × λz) |
| AUC0-t | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured |
| Adverse events | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | AE and SAE |
| Immunogenicity | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA. |
| λz | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | 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 |
| Tmax | Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 | Observed time to peak concentration |
Countries
China
Outcome results
None listed