NCT06431438

Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 759 (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 single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TQA3810	TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2024-05-28
• Last updated: 2024-05-28

Locations

1 site across 1 country: China