Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

A Randomized, Double-blinded, Single-dose, 3-arm Parallel Comparative Study on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects

To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.

Study Overview

• Status: Completed
• Conditions: Severe Asthma
• Intervention / Treatment: Drug: Mepolizumab Injection (BAT2606 Injection); Drug: Mepolizumab Injection (EU-licensed Nucala); Drug: Mepolizumab Injection (US-licensed Nucala)

Detailed Description

This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT2606 Injection; PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.	Drug: Mepolizumab Injection (BAT2606 Injection); In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.; Other Names: BAT2606 Injection
Active Comparator: Mepolizumab Injection (EU-licensed Nucala®); PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.	Drug: Mepolizumab Injection (EU-licensed Nucala); In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).; Other Names: EU-licensed Nucala
Active Comparator: Mepolizumab Injection (US-licensed Nucala®); PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.	Drug: Mepolizumab Injection (US-licensed Nucala); In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).; Other Names: US-licensed Nucala

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: Yanhua Ding, PhD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BAT-2606-001-CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No