A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis

Inclusion Criteria

• Diagnosis of RA and meeting the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA.
• Patients between the ages of 18 and 64 years, inclusive, at the Screening Visit.
• Female patient must be not pregnant, not breast feeding and one of the following conditions need to apply:
• Of non-childbearing potential based on documented surgical treatment or post-menopausal, meaning patient had spontaneous amenorrhea for at least 12 months without alternate medical cause prior to Screening Visit and follicle stimulating hormone (FSH) > 40 U/mL at the Screening Visit.
• Of childbearing potential and using a highly effective method of contraception and agrees to remain on a highly effective method from the time of signing the informed consent form (ICF) until 21 days after the last dose.
• Male patient must agree to stay abstinent or must use together with his female partner(s) a form of highly effective contraceptive (failure rate of 450 ms for males or QTcF > 470 ms for females either at the Screening Visit or Admission, based on safety 12-lead electrocardiogram (ECG). Patient has Screening or Admission ECG with second- or third-degree atrioventricular block, bundle branch block, arrhythmia (but not sinus arrhythmia or supraventricular premature beats), or illegible QT interval.
• Patient has history or evidence of cardiopathy, acute coronary syndrome, hypertrophic cardiomyopathy, myocarditis or QT prolongation syndrome.
• Patient is unwilling to abstain from drinks and foods containing alcohol, grapefruit, or caffeine
• Patient has donated blood or experienced acute blood loss (including plasmapheresis) of greater than 500 mL within 90 days prior to the first dose of study drug.
• Patients with a known immunodeficiency disorder. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
• Patients with infections requiring treatment or hospitalization within 14 days prior to the Screening Visit, parenteral antimicrobial therapy within 60 days prior to the Screening Visit, infected joint prosthesis; history of herpes zoster, active herpes simplex, or herpes simplex on suppressive therapy.
• Patient has a chronic hepatic disease or hepatic impairment.
• Patient has a history of Mycobacterium tuberculosis or positive interferon gamma release assay for tuberculosis (IGRA-TB) or abnormal chest X-ray (for positive IGRA-TB patients).
• Patient has a history of any lymphoproliferative disorder.
• Patient has a history of COVID-19 unless fully recovered with no sequelae for 14 days.
• Patient who had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
• Patient who has recent exposure to someone who has COVID-19 symptoms or positive test result.
• Patient who has a positive reverse transcription polymerase chain reaction (RT-PCR) test for Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2).
• Patient who has clinical signs and symptoms consistent with SARS-CoV-2 infection.
• Patients may not receive any live/attenuated vaccine from 30 days prior to the Screening Visit until Day 14 Follow-up Visit.
• COVID-19 vaccine should not be given 1 week prior to the Screening Visit.
• Patients with malignancy or history of malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Previous treatment with total lymphoid irradiation.
• History of recurrent inflammatory joint disease other than RA or history of any other autoimmune rheumatic diseases other than Sjogren's syndrome.
• Major surgery within 30 days prior to the Screening Visit or patients with planned surgery.
• Patients who have an abnormal chest X-ray for interstitial lung disease (ILD) and/or patients with history of ILD.
• History of fainting or family history of sudden death.
• Patient has any disorder that would interfere with the absorption, distributio