NCT05468060

Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics of Single Ascending Dose (SAD) of PA1010 Tablets in Chinese Healthy Subjects and the Effects of Food and Gender on Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Zhejiang Palo Alto Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	PA1010	Placebo as control

Timeline

• Start date: 2020-06-28
• Primary completion: 2020-12-12
• Completion: 2020-12-12
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

1 site across 1 country: China