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

  • End date
    Mar 22, 2022
  • participants needed
  • sponsor
    Zhejiang Palo Alto Pharmaceuticals, Inc.
Updated on 22 October 2021


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.


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.

Condition Chronic HBV Infection
Treatment PA1010
Clinical Study IdentifierNCT05019040
SponsorZhejiang Palo Alto Pharmaceuticals, Inc.
Last Modified on22 October 2021


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