Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

Bio-Thera Solutions

Status and phase: Completed; Phase 1

Conditions: Severe Asthma

Treatments: Drug: Mepolizumab Injection (US-licensed Nucala); Drug: Mepolizumab Injection (EU-licensed Nucala); Drug: Mepolizumab Injection (BAT2606 Injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05576454

BAT-2606-001-CR

Details and patient eligibility

About

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

Full description

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

Enrollment: 207 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 3 patient groups

BAT2606 Injection

Experimental group

Description:

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

Treatment:

Drug: Mepolizumab Injection (BAT2606 Injection)

Mepolizumab Injection (EU-licensed Nucala®)

Active Comparator group

Description:

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

Treatment:

Drug: Mepolizumab Injection (EU-licensed Nucala)

Mepolizumab Injection (US-licensed Nucala®)

Active Comparator group

Description:

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

Treatment:

Drug: Mepolizumab Injection (US-licensed Nucala)