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Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients

Chronic HBV Infection Clinical Trial

Official title:
A Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple Ascending Dose (MAD) of PA1010 Tablets in Chinese Patients With Chronic Hepatitis B Infection

Clinical Trial Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in Chinese adults with Chronic Hepatitis B.

Clinical Trial Description

This is a multicenter, randomized, open-label, controlled, dose-escalation clinical trial, the objective is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of PA1010 tablets in Chinese patients with Chronic Hepatitis B (CHB). There are three dose groups of PA1010 ( 5 mg, 10 mg, and 20 mg) proposed to be tested sequentially in this study. A total of 36 patients with CHB, either hepatitis B e antigen (HBeAg)-positive (+) or HBeAg-negative (-), are planned to be enrolled in this study and will be stratified by HBeAg status by the ratio of 2: 1, that is, 24 of HBeAg + and 12 of HBeAg- patients. Twelve subjects in each dose group were randomly assigned in a 3: 1 ratio to receive either PA1010 tablets or or tenofovir disoproxil fumarate (TDF) tablets. All patients will be dosed for 28 consecutive days, and the dose-related safety, PK, and antiviral efficacy of PA1010 will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05019040
Study type Interventional
Source Zhejiang Palo Alto Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 17, 2021
Completion date November 18, 2022
View Details
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