Clinical Trials Directory

Trials / Completed

CompletedNCT05019040

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Zhejiang Palo Alto Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGPA1010TDF as control

Timeline

Start date
2021-09-17
Primary completion
2022-11-15
Completion
2022-11-18
First posted
2021-08-24
Last updated
2023-01-31

Locations

4 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05019040. Inclusion in this directory is not an endorsement.