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Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ003234 | Experimental | Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion |
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| Placebo | Placebo Comparator | Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ003234 injection | Biological | Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subject with adverse events(AEs) | Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations | First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234 | AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234 | Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part |
| Maximum observed plasma concentration (Cmax) of TJ003234 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhanguo Li | Contact | +86010-88326666 | li99@bjmu.edu.cn | |
| yingchao Zhou | Contact | +86010-56176269 | yingchao.zhou@i-mabbiopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Recruiting | Bengbu | Anhui | China |
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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 |
|---|---|
| C000711830 | plonmarlimab |
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Randomized, Double-blind, Placebo-controlled
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Double-blind
Maximum observed plasma concentration (Cmax) of TJ003234 |
| Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part |
| The proportion of subjects who produce anti-drug antibodies | The proportion of subjects who produce anti-drug antibodies | Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part |
| The proportion of subjects who produce neutralizing antibodies | The proportion of subjects who produce neutralizing antibodies | Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part |
| The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies | The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies | Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part |
| Peking university people's Hospital | Recruiting | Beijing | Beijing Municipality | 10044 | China |
|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | China |
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| Zhongda Hospital southeast university | Recruiting | Nanjing | Jiangsu | China |
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| FuDan University shanghai huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |