Healthy Subjects Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled, Single-Centre,Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers
The study consists of 10 dose groups, 8 subjects in each group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and pharmacokinetics characteristics.
The dose levels are planned at 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg,40 mg, 60 mg ,90 mg and 120mg. 6 subjects in each group will receive LV232 tablets and 2 subjects will receive placebo. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained.1 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial. ;
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