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This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.
This is a comparative, open, randomized clinical study. The purpose of the study is to demonstrate that human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection is equivalent to adalimumab in terms of pharmacokinetics and safety after single subcutaneous injection in Chinese healthy volunteers.The study will enroll 180 healthy volunteers, who will be randomized into 2 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monoclonal antibody injection | Experimental | human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once |
|
| adalimumab | Active Comparator | adalimumab 40mg administered subcutaneously once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection | Drug | human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast) | 71days | |
| Area under the concentration-time curve from time zero to infinity(AUCinf) | 71days | |
| Maximum serum concentration(Cmax) | 71days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach the maximum concentration(Tmax) | 71days | |
| Elimination rate constant(γz) | 71days | |
| Terminal half-live(T1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bei Hu, Professor | Peking Union Medical College Hospital | Principal Investigator |
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| adalimumab | Drug | adalimumab, 40mg,subcutaneous injection,once |
|
| 71days |
| Apparent clearance(CL/F) | 71days |
| Apparent volume of distribution(V/F) | 71days |
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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