drugset / Trial / NCT07408024
Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis
RandomizedSequentialQuadruple-blindTreatment
Summary
The goal of this study is to evaluate the safety, pharmacokinetic (PK) characteristics, and preliminary efficacy of a new oral chemical drug in : adults aged 18-70 years (male or female) with moderate to severe active rheumatoid arthritis (RA), who have had inadequate response to or intolerance of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) . Participants will take the assigned study drug (either tollB-001 Tablets or placebo) once daily orally for 4 weeks, follow up for 1 week.
Timeline
- Start
- 2025-09-10
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TollB-001 | Small molecule | 100 mg | Oral |
| Subject | TollB-001 | Small molecule | 200 mg | Oral |
| Subject | TollB-001 | Small molecule | 400 mg | Oral |