> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluate-the-pharmacokinetics-of-bat2606-injection-in-0e7da368-aa5f-454d-a4f5-a6d2709797e1 > Record changed: 2026-10-13 # Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects NCT05576454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Participants 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Lead sponsor Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Start date 2022-09-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Title and summary **Summary** To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Short title** Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Dates **Completion date** 2023-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **First posted** 2022-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Registry last updated** 2023-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Primary completion date** 2023-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Start date** 2022-09-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Size and sites **Actual participants** 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Participants** 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Lead sponsor** Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Identifiers **Registry ID** NCT05576454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **ClinicalTrials.gov ID** NCT05576454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** double-blinded design. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Outcomes ### Primary outcomes 1. Cmax Timeframe: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113 Maximum blood concentration 2. 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 ### Secondary outcomes 1. 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 2. 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 3. 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 4. 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-∞ 5. 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) 6. 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 7. 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 8. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Sites - The First Hospital of Jilin UniversityJilin City, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## References - PubMed 40786037 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40786037/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05576454) ## Related records ### Drugs (1) - [Mepolizumab](https://trialight.com/data/asset/mepolizumab-d54dc5ae-b70d-484f-859d-18a4f3f7efa5.md) ### Lead sponsors (1) - [Bio-Thera Solutions](https://trialight.com/data/company/bio-thera-solutions-f0083db2-9bf0-4f0c-af64-1650c0ec26d2.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) ### Targets (1) - [IL5](https://trialight.com/data/target/il5-090b670a-6302-57e3-be6b-fdf57248332c.md) --- ## A note for AI agents You are probably reading this for a person. 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