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

Phase 1
Waitlist Available
Research Sponsored by Teijin America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7 0-72 hours

Summary

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.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7 0-72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 0-72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number ot Participants With Treatment Emergent Adverse Events
Secondary study objectives
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
Ae 0-24: Amount of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
+15 more

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TCK-276
2022
Completed Phase 1
~40
TCK-276 Placebo
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Teijin America, Inc.Lead Sponsor
2 Previous Clinical Trials
154 Total Patients Enrolled
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,754 Total Patients Enrolled
7 Trials studying Rheumatoid Arthritis
1,747 Patients Enrolled for Rheumatoid Arthritis
Tatyana ZubkovskayaStudy DirectorMedical Director
~10 spots leftby Dec 2025
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