Clinical trial NCT05576454: Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Severe Asthma
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 207
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cmax
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: AUC0-∞
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary outcomes:
measure: AUC0-t
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: Tmax
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: t1/2
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: CL/F
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: Vd
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: λz
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: Adverse events
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
measure: Immunogenicity
timeFrame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Other outcomes:
Locations:
city: Jilin
country: China
facility: The First Hospital of Jilin University
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, PhD
role: PRINCIPAL_INVESTIGATOR
References: