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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 BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the 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 |
|---|---|---|---|
| BAT2206 injection | Experimental | 45mg; subcutaneous injection |
|
| Stelara(US-licensed) | Active Comparator | 45mg; subcutaneous injection |
|
| Stelara(EU-licensed) | Active Comparator | 45mg; subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT2206 | Drug | 45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint: Peak plasma concentration (Cmax) | 0-4months | |
| Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf) | 0-4months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding | the First Hospital of Jinlin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36417156 | Derived | Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22. |
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Only one site study
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Stelara(US-licensed) |
| Drug |
45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection |
|
|
| Stelara(EU-licensed) | Drug | 45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |