NCT06103773

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Toll Biotech Co. Ltd. (Beijing) · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TollB-001 tablets	TollB-001 treatment
DRUG	TollB-001 placebo	TollB-001 Placebo

Timeline

• Start date: 2023-09-28
• Primary completion: 2024-06-09
• Completion: 2024-06-09
• First posted: 2023-10-27
• Last updated: 2023-10-27

Locations

1 site across 1 country: China