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It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT1806 injection | Experimental | BAT1806 injection: 4 mg/kg, intravenous infusion over 60 min |
|
| Actemra(EU-licensed) | Active Comparator | Actemra(EU-licensed): 4 mg/kg, intravenous infusion over 60 min |
|
| Actemra(US-licensed) | Active Comparator | Actemra(US-licensed): 4 mg/kg, intravenous infusion over 60 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT1806 injection | Drug | Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint | AUC0-inf | 0-2months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint | AUC0-t | 0-2months |
| Pharmacokinetics Endpoint | Cmax | 0-2months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yanhua ding | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40198544 | Derived | 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. | |
| 33569002 | Derived | 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. |
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Only one site study
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |