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This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC005 Tablets Low Dose groups | Experimental |
| |
| VC005 Tablets Medium Dose groups | Experimental |
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| VC005 Tablets High Dose groups | Experimental |
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| VC005 Tablets Placebo Low Dose groups | Experimental |
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| VC005 Tablets Placebo Medium Dose groups | Experimental |
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| VC005 Tablets Placebo High Dose groups | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC005 tablets | Drug | VC005 groups repeat administration for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak time in plasma(Tmax) | Day1、Day8、Day15、Day22、Day28 | |
| Peak Plasma Concentration (Cmax) | Day1、Day8、Day15、Day22、Day28 |
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Inclusion Criteria:
Exclusion Criteria:
The subjects who are allergic to the study drug or any of the components of the study drug, or are allergic (multiple drug and food allergies);
The subjects have used any of the following medications or treatments:
Tyrosine kinase (JAK) inhibitor class drugs, within 1 month prior to randomization/biologic disease-modifying antirheumatic drugs (bDMARDs) within 5 half-lives prior to randomization or within 3 months,etc;
The subjects have a history or evidence of any of the following diseases:
Presence of any systemic inflammatory disease other than RA (except secondary dry syndrome)/lymphoproliferative disease, etc;
The presence of any abnormal laboratory test at screening that meets the following criteria (not allowed to receive within 2 weeks prior to screening) Any medical support therapy such as leukocyte boosting, anemia improvement, liver protection and enzyme reduction, blood transfusion, etc;
Positive hepatitis B surface antigen (HBsAg) or negative hepatitis B surface antigen, negative hepatitis B surface antibody, positive hepatitis B core antibody (HBcAb) with hepatitis B virus honeybee venom(HBV)-DNA test results above the lower limit of detection; positive hepatitis C antibody (HCVAb) with hepatitis C virus ribonucleic acid (HCV-RNA) test results above the lower limit of detection; positive syphilis spirochete antibody (TPAb) ,etc;
Screening period ECG corrected QT interval(QTC): > 470 ms for men and > 480 ms for women, or abnormalities of clinical significance that, in the judgment of the investigator, preclude enrollment;
Those with a history of substance abuse or drug use within the past five years;
Those who have a positive urine drug screen or alcohol screen;
Female patients who are planning to become pregnant or who are pregnant or breastfeeding, or who are unable to use effective contraception throughout the trial and for 6 months after the trial ends;
Who, for any reason, are deemed by the investigator to be unsuitable for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding | The First Hospital of Jilin University | Principal Investigator |
| Nanya Wang | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130061 | 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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| VC005 Tablets Placebo | Drug | VC005 placebo groups repeat administration for 4 weeks |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |