> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-randomized-double-blind-single-dose-two-arm-parallel-study-ade1ae5a-3362-4019-953f-a4d54f732f92 > Record changed: 2026-10-13 # A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects NCT05968508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Lead sponsor Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Start date 2023-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Title and summary **Summary** This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Short title** A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Official title** A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Dates **Completion date** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **First posted** 2023-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Registry last updated** 2025-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Primary completion date** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Start date** 2023-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Size and sites **Actual participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Lead sponsor** Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Identifiers **Registry ID** NCT05968508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **ClinicalTrials.gov ID** NCT05968508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Outcomes ### Primary outcomes 1. AUC0-inf Timeframe: from Day0 to Day57 2. AUC0-t Timeframe: from Day0 to Day57 3. Cmax Timeframe: from Day0 to Day57 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - Subjects can be enrolled only when they meet all the following inclusion criteria: 1. Signed the informed consent form prior to the study, sufficient understanding of the content, procedure and possible adverse reactions of the study; 2. Willing and able to comply with the visit and treatment specified in the study; 3. Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e., 6 months after study medication), see Appendix 4 for the detailed contraceptive measures; 4. Healthy male subjects aged 18～55 years (inclusive); 5. BMI ranging from 18.0～28.0 kg/m2 (inclusive), and weight ranging from 55.0～85.0 kg (inclusive); 6. Normal or abnormal physical examination that is judged as clinically insignificant; ### Exclusion criteria - Subjects can not be enrolled in this study if any of the following criteria is met: 1. Smoking >5 cigarettes per day within three months prior to the study; 2. Any serious allergic reaction to food or drug at present or in the past, or allergy to Tocilizumab, or serious allergy or allergic reaction to human, humanized or murine monoclonal antibody; 3. History of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL liquor, or 125 mL wine); 4. Blood donation or massive blood loss (>450 mL) within three months prior to screening, or plan for blood donation or surgery during the study; 5. Intake of any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days prior to screening; 6. Great change in dietary or exercise habit within 2 weeks prior to screening or from screening to administration; 7. Having any disease that may increase hemorrhagic risk, such as haemorrhoids with hemorrhagic symptoms, acute gastritis or gastric and duodenal ulcer; 8. Clinically significant abnormality in echocardiography; 9. Clinically significant abnormality in clinical laboratory examination, or other clinical findings showing the following disorders of clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and cardiovascular diseases); 10. Clinically significant (judged by investigators) abnormality in ECG, or QTcF > 450ms (allowed to be repeated for once, the subject needs to be excluded if the two measurements of QTcF are > 450ms); 11. Acute disease or concomitant medication from screening to prior to administration of study drug; 12. Positive urine drug screen, or history of drug abuse or use of narcotics in the past 5 years; 13. Positive HBsAg in five hepatitis B markers at screening; or positive anti-HBc and negative anti-HBs; or positive hepatitis C antibody; or positive HIV antibody; or positive Treponema pallidum antibody; 14. Intake of any alcohol-containing product within 48 hours prior to dosing of study drug, or failure to limit alcohol consumption as required during the study; 15. Currently or previously having malignant tumor; 16. History of hypertension, or systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥90 mmHg at screening/baseline (allowed to be repeated for once, the subject needs to be excluded if the two measurements of systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥90 mmHg); 17. Patients with hepatic disorder who are judged by investigators as inappropriate for enrollment; 18. Presence of active infection, including acute and chronic infection as well as local infection; 19. Chest X-ray showing active pulmonary tuberculosis; or previous history of tuberculosis or latent tuberculosis infection, or clinical manifestations suspected as tuberculosis (including but not limited to pulmonary tuberculosis); Positive for T-SPOT®.TB interferon-γ-release assays, or contact with patients with tuberculosis within three months or/and symptoms or/and signs suspected as tuberculosis; 20. Had received or plan to receive live virus vaccine or immunosuppressant within 12 weeks prior to administration of study drug; 21. Having participated in drug clinical trial within three months prior to the first dose of study drug, or plan to participate in other drug clinical trial during the study; 22. Those who are considered by investigators as inappropriate for enrollment. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Sites - The Second Affiliated Hospital of Anhui Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## References - PubMed 41069221 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41069221/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968508) ## Related records ### Drugs (1) - [Tocilizumab](https://trialight.com/data/asset/tocilizumab-58fcf741-84ea-43ec-ab1b-8fc8d306b59d.md) ### Lead sponsors (1) - [Bio-Thera Solutions](https://trialight.com/data/company/bio-thera-solutions-f0083db2-9bf0-4f0c-af64-1650c0ec26d2.md) ### Targets (1) - [IL6R](https://trialight.com/data/target/il6r-c7147d9a-d486-5e5b-9263-4bf4c1ee3a1a.md) --- ## A note for AI agents You are probably reading this for a person. 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