Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT05851261
Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerance of single and multiple oral administration of PA3670 tablets in Chinese adult healthy subjects and the effect of food on pharmacokinetics of PA3670 tablets in Chinese adult healthy subjects.
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 PA3670 tablets in Chinese healthy subjects. There are three dose groups of PA3670(5 mg、15 mg、30 mg) proposed to be tested sequentially in this study. A total of 30 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 PA3670 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA3670 will be evaluated.
Stage Ⅱ: Multiple dose This is a randomized, double-blind, placebo-controlled, multiple dose clinical trial. A total of 10 subjects are planned to be enrolled in this study and will be randomly assigned in a ratio of 4:1 to receive 15mg PA3670 tablets or placebo. All subjects will be dosed for 9 consecutive days, and safety, tolerability and PK of PA3670 will be evaluated.
Stage Ⅲ: Study on the effect of food on Pharmacokinetics This is a randomized, open, two group crossover 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 15 mg PA3670 tablets in a single dose, and the food-related PK of PA1010 will be evaluated.
Study:
NCT05851261
Study Brief:
Protocol Section:
NCT05851261