drugset / Trial / NCT05808374

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

NCT05808374

Phase 1 Unknown 85 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindBasic science

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.

Timeline

Start
2023-04-30
Primary completion
2024-05-31
Completion
2024-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HRS-5635 Unknown 50 mg
Subject HRS-5635 Unknown 100 mg
Subject HRS-5635 Unknown 200 mg
Subject HRS-5635 Unknown 400 mg
Subject HRS-5635 Unknown 600 mg
Subject HRS-5635 Unknown 800 mg