NCT05380934

A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects. The main purpose was to evaluate the safety and tolerance of different doses of TQH3821 or in combination with methotrexate tablets after single and multiple administration in healthy subjects.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TQH3821 tablets	TQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase.
DRUG	TQH3821 tablets (Placebo)	TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase.
DRUG	Methotrexate tablets	Methotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition

Timeline

• Start date: 2022-05-29
• Primary completion: 2023-05-20
• Completion: 2023-05-20
• First posted: 2022-05-19
• Last updated: 2024-01-22

Locations

1 site across 1 country: China