A Study of Single and Multiple Oral Doses of TollB-001

Rheumatoid Arthritis Clinical Trial

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses and to Evaluate the Food Effect of TollB-001

Status Recruiting

Clinical Trial Summary

The primary objective is to evaluate the safety and tolerability of TollB-001 following the administration of single or multiple oral doses in healthy adult subjects

Clinical Trial Description

This is a Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of single or multiple dose(s) of TollB-001 administered orally in healthy adult subjects and the food effect on the PK of a single dose of TollB-001 with a randomized, open-label and two-period crossover design.

This study includes three parts. Part A: single ascending dose (SAD) study; Part B: multiple ascending dose (MAD) study; and Part C: FE study. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT06103773
• Study type: Interventional
• Source: Toll Biotech Co. Ltd. (Beijing)
• Contact: min xv, Master
• Phone: 15198081852
• Email: Xm15198081852@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: September 28, 2023
• Completion date: June 9, 2024