Clinical Trials Logo

Clinical Trial Summary

The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetics characteristics of single ascending dose (SAD) of PA1010 tablets in Chinese healthy adults and the impact of food and gender on the pharmacokinetics


Clinical Trial Description

Stage I: Single dose, Single Ascending Dose (SAD) This is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial. The objective is to evaluate the safety, tolerability and pharmacokinetics characteristics of PA1010 tablets in Chinese healthy subjects. There are six dose groups of PA1010 ( 5 mg、10 mg、20 mg、30 mg、45 mg and 60 mg) proposed to be tested sequentially in this study. A total of 60 healthy subjects are planned to be enrolled in this study and will be randomly assigned to the corresponding dose group in equal proportion, stratified by gender (male vs female). 10 subjects in each dose group are randomly assigned in a ratio of 4:1 to receive PA1010 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA1010 will be evaluated. Stage II: Study on the effect of food on Pharmacokinetics This is a single center, randomized, open, two group crossover, self-control clinical trial. A total of 20 subjects are planned to be enrolled in this study, and will be randomly assigned to a dosing order (i.e. fasting administration followed by high-fat meal administration, or high-fat meal administration followed by fasting administration) in a ratio of 1:1. Subjects will be dosed 10 mg PA1010 tablets in a single dose, and the food-related PK of PA1010 will be evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05468060
Study type Interventional
Source Zhejiang Palo Alto Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 28, 2020
Completion date December 12, 2020

See also
  Status Clinical Trial Phase
Completed NCT04470388 - A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment Phase 1
Completed NCT05019040 - Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients Phase 1/Phase 2
Completed NCT01943799 - Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B Phase 2
Recruiting NCT05792761 - A Study on Antiviral Treatment of Chronic Hepatitis B in Children N/A
Completed NCT04008004 - A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2) Phase 1
Active, not recruiting NCT05734807 - A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia Phase 2
Completed NCT06029634 - Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
Completed NCT04147208 - Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection Phase 2
Completed NCT03909191 - Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
Completed NCT03664518 - to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection Phase 2
Completed NCT05542979 - A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection Phase 1
Active, not recruiting NCT03903796 - Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection Phase 3
Completed NCT05851261 - Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects Phase 1