Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

NCT ID: NCT05576454

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-06-19

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.

Conditions

Severe Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BAT2606 Injection

PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

Group Type: EXPERIMENTAL

Mepolizumab Injection (BAT2606 Injection)

Intervention Type: DRUG

In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.

Mepolizumab Injection (EU-licensed Nucala®)

PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

Group Type: ACTIVE_COMPARATOR

Mepolizumab Injection (EU-licensed Nucala)

Intervention Type: DRUG

In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).

Mepolizumab Injection (US-licensed Nucala®)

PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

Group Type: ACTIVE_COMPARATOR

Mepolizumab Injection (US-licensed Nucala)

Intervention Type: DRUG

In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).

Interventions

Mepolizumab Injection (BAT2606 Injection)

In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.

Intervention Type: DRUG

Mepolizumab Injection (EU-licensed Nucala)

In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).

Intervention Type: DRUG

Mepolizumab Injection (US-licensed Nucala)

In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).

Intervention Type: DRUG

Other Intervention Names

BAT2606 Injection; EU-licensed Nucala; US-licensed Nucala

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bio-Thera Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The First Hospital of Jilin University

Jilin, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40786037 (View on PubMed)

Other Identifiers

BAT-2606-001-CR

Identifier Type: -

Identifier Source: org_study_id