Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects
NCT ID: NCT03606876
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
138 participants
INTERVENTIONAL
2018-06-13
2019-07-17
Brief Summary
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The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and similarity of the pharmacokinetics of the three study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAT1806 injection
BAT1806 injection: 4 mg/kg, intravenous infusion over 60 min
BAT1806 injection
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
Actemra(EU-licensed)
Actemra(EU-licensed): 4 mg/kg, intravenous infusion over 60 min
BAT1806 injection
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
Actemra(US-licensed)
Actemra(US-licensed): 4 mg/kg, intravenous infusion over 60 min
BAT1806 injection
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
Interventions
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BAT1806 injection
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to follow the visits, treatments specified in this study;
* 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 specific contraceptive methods;
* Healthy male subjects at age of 18-55 years (inclusive for both);
* BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg (inclusive for both);
* Normal physical examinations results or abnormality without clinical significance.
Exclusion Criteria
* Any current or history of severe allergic reaction to foods or drugs and History of allergy to tocilizumab or severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
* Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 125 mL wine);
* Having donated blood or loss of massive blood (\> 450 mL) within 3 months prior to screening, or planning to donate blood or to receive surgery during the study;
* Prior use of prescription medication, over-the-counter drugs, any vitamin products or herbs within 28 days before screening;
* Having significant changes in diet and exercise habits within 2 weeks before screening or from screening to dose;
* Having any diseases that increase the risk of bleeding, such as hemorrhoids with bleeding symptoms, acute gastritis or gastric and duodenal ulcers;
* Color Doppler echocardiography abnormalities with clinical significance;
* Having clinically significant laboratory abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
* Ineligible subjects based on investigator's judgement.
18 Years
55 Years
MALE
Yes
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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yanhua ding
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Countries
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References
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Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.
Zhang H, Wang H, Wei H, Chen H, Liu J, Li C, Zhu X, Li X, Yu J, Zhou Y, Yang X, Wang Z, Wu M, Ding Y. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Front Pharmacol. 2021 Jan 25;11:609522. doi: 10.3389/fphar.2020.609522. eCollection 2020.
Other Identifiers
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BAT-1806-001-CR
Identifier Type: -
Identifier Source: org_study_id