NCT05437419

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

A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teijin America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, multiple ascending dose (MAD) study. The study will consist of a Screening Visit (Days -1 to Day 10), Treatment duration (up to 11 days) and a Follow-up/end of treatment (EOT) visit. This MAD study will consist of 4 cohorts of 8 patients (6 active treatment and 2 matching placebo, or a 3:1 ratio), each receiving an oral dose of TCK-276 or matching placebo for 7 days (once daily (QD) under fed condition). The first cohort will be divided into 2 subgroups to implement the sentinel dosing approach. The study duration is approximately 42 days.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2023-07-20
• Completion: 2023-07-27
• First posted: 2022-06-29
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study