Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

Phase 1

Completed

• Conditions: Severe Asthma
• Interventions: Drug: Mepolizumab Injection (US-licensed Nucala); Drug: Mepolizumab Injection (EU-licensed Nucala); Drug: Mepolizumab Injection (BAT2606 Injection)

• Registration Number: NCT05576454
• Lead Sponsor: Bio-Thera Solutions

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.

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Status Verified: 2023-02
• Primary Completion: 2023-05-26
• Study Completion: 2023-06-19
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 207

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepolizumab Injection (US-licensed Nucala®)	Mepolizumab Injection (US-licensed Nucala)	PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.
Mepolizumab Injection (EU-licensed Nucala®)	Mepolizumab Injection (EU-licensed Nucala)	PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.
BAT2606 Injection	Mepolizumab Injection (BAT2606 Injection)	PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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-∞
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.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Jilin, China