Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

Severe Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576454
• Other study ID #: BAT-2606-001-CR
• Status: Completed
• Phase: Phase 1
• Start date: September 20, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: February 2023
• Source: Bio-Thera Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 19, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Severe Asthma

Intervention

Drug:
• Mepolizumab Injection (BAT2606 Injection)
In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.
• Mepolizumab Injection (EU-licensed Nucala)
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).
• Mepolizumab Injection (US-licensed Nucala)
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum blood concentration	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Primary	AUC0-8	Area under the plasma concentration-time curve from zero to infinity, AUC0-8 = AUC0-t + Ct/?z	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary	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
Secondary	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
Secondary	t1/2	Elimination half-life t1/2 = 0.693/?z	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary	CL/F	Total clearance rate, CL/F=Dose/AUC0-8	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary	Vd	Apparent volume of distribution, Vd =Dose/(AUC0-8 × ?z)	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary	?z	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
Secondary	Adverse events	AE and SAE	Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary	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