drugset / Trial / NCT06431438

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

NCT06431438

Phase 1 Completed 759 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2021-10-01
Primary completion
2023-11-20
Completion
2023-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject TQA3810 Small molecule 0.1 mg
Subject TQA3810 Small molecule 0.2 mg
Subject TQA3810 Small molecule 0.3 mg
Subject TQA3810 Small molecule 0.5 mg
Subject TQA3810 Small molecule 1 mg