Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects
- Summary
- To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-06-19
- First posted
- 2022-10-12
- Registry last updated
- 2023-08-28
- Primary completion date
- 2023-05-26
- Start date
- 2022-09-20
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bio-Thera Solutions
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05576454
- ClinicalTrials.gov ID
- NCT05576454
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- double-blinded design.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Cmax
Timeframe: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Maximum blood concentration
AUC0-∞
Timeframe: 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
AUC0-t
Timeframe: 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
Tmax
Timeframe: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Observed time to peak concentration
t1/2
Timeframe: 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
CL/F
Timeframe: 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-∞
Vd
Timeframe: 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)
λz
Timeframe: 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
Adverse events
Timeframe: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
AE and SAE
Immunogenicity
Timeframe: 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.
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- The First Hospital of Jilin UniversityJilin City, China
- PubMed 40786037Related publication