Healthy Subjects Clinical Trial
Official title:
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules in Chinese Healthy Volunteers
This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement.
PK characteristics of multiple ascending doses study is used randomized, double-blinded, placebo-controlled, single-center design. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (15mg, 25mg and 40mg), 8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. Investigational product is orally administrated QD for day1, day3~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted. FE study is a single-center, randomized, open-label, three-period crossover design. 24 healthy subjects divided into 2 groups will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. There are 2 dose groups (25mg and 40mg) and wash-out period is 5 days. ;
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