Skip to main content
OpenTrials
Completed

NCT Number: NCT05576454

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of Jilin University

Jilin City, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepolizumab Injection (BAT2606 Injection)

Drug

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

Other names: BAT2606 Injection

Mepolizumab Injection (EU-licensed Nucala)

Drug

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

Other names: EU-licensed Nucala

Mepolizumab Injection (US-licensed Nucala)

Drug

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

Other names: US-licensed Nucala

Primary outcomes

  1. Cmax

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

    Maximum blood concentration

  2. AUC0-∞

    Time frame: 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 outcomes

  1. AUC0-t

    Time frame: 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

  2. Tmax

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

    Observed time to peak concentration

  3. t1/2

    Time frame: 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

  4. CL/F

    Time frame: 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-∞

  5. Vd

    Time frame: 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)

  6. λz

    Time frame: 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

  7. Adverse events

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

    AE and SAE

  8. Immunogenicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bio-Thera Solutions

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2022
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.