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

NCT05437419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-15

Study results available
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Summary

The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).

Conditions

Interventions

DRUG

TCK-276

Patients will receive an oral dose of TCK-276 QD under fed conditions from Day 1 to Day 7.

DRUG

TCK-276 Placebo

Patients will receive an oral dose of TCK-276 matching placebo QD under fed conditions from Day 1 to Day 7.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Teijin America, Inc.

    lead INDUSTRY

Principal Investigators

  • Tatyana Zubkovskaya · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2023-07-20
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437419 on ClinicalTrials.gov