A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Teijin America, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests a new oral medicine called TCK-276 in people with Rheumatoid Arthritis. It aims to see if the medicine is safe, well-tolerated, and how it moves through and affects the body.
Research Team
TZ
Tatyana Zubkovskaya
Principal Investigator
Medical Director
Eligibility Criteria
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
Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive, at the Screening Visit
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Exclusion Criteria
Patient with any of the laboratory abnormalities as per reference
You have had a serious allergic reaction to a medication in the past.
You have taken any study medications, medications that are not allowed, over-the-counter drugs, vitamins, or herbal supplements.
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Treatment Details
Interventions
- TCK-276 (Unknown)
- TCK-276 Placebo (Drug)
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
The patient will receive Dose D of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Group II: Cohort 3Experimental Treatment2 Interventions
The patient will receive Dose C of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Group III: Cohort 2Experimental Treatment2 Interventions
The patient will receive Dose B of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Group IV: Cohort 1Experimental Treatment2 Interventions
The patient will receive Dose A of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SMS Clinical ResearchMesquite, TX
Allied Biomedical Research InstituteMiami, FL
Clinical Site Partners, LLC dba CSP OrlandoWinter Park, FL
SMS Clinical Research, LLCMesquite, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Teijin America, Inc.
Lead Sponsor
Trials
3
Patients Recruited
190+
Parexel
Industry Sponsor
Trials
322
Patients Recruited
137,000+