The goal of this study is to evaluate the safety, pharmacokinetic (PK) characteristics, and preliminary efficacy of a new oral chemical drug in : adults aged 18-70 years (male or female) with moderate to severe active rheumatoid arthritis (RA), who have had inadequate response to or intolerance of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) .
Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.
Diagnosis of RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
DAS28-CRP > 3.2 at screening.
C-reactive protein (CRP)/high-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) at screening.
Hypersensitivity to the study drug or any of its components.
ACR functional class IV or being bedridden/wheelchair-bound for a long time.
Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV DNA above the lower limit of detection; positive hepatitis C virus (HCV) antibody with positive HCV-RNA; positive human immunodeficiency virus (HIV) antibody or positive syphilis antibody.
Drug or alcohol abuse or dependence at screening, or history of drug or alcohol abuse or dependence within 6 months before randomization.
Sequential
TollB-001
DrugTollB-001 Tablets
Placebo
DrugPlacebo Tablets
Safety-AE/lab tests/PE/VS/ECG
Safety parameters including the incidence of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs, and routine 12-lead electrocardiograms
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