[Translation] A randomized, double-blind, placebo- and active-controlled phase I clinical study evaluating the safety and tolerability of HRL1101 powder in healthy participants.
主要目的:
评价在健康参与者中单次、多次口服HRL1101散后的安全性、耐受性。
次要目的:
1. 评价在健康参与者中单次、多次口服HRL1101散后的药代动力学特征;
2. 探索健康参与者单次口服HRL1101散后的代谢与排泄特征;
3. 评价在健康参与者中单次、多次口服HRL1101散后的药效动力学特征。
[Translation] Primary Objective: To evaluate the safety and tolerability of HRL1101 powder after single and multiple oral administrations in healthy participants.
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of HRL1101 powder after single and multiple oral administrations in healthy participants;
2. To explore the metabolic and excretion characteristics of HRL1101 powder after a single oral administration in healthy participants;
3. To evaluate the pharmacodynamic and pharmacokinetic characteristics of HRL1101 powder after single and multiple oral administrations in healthy participants.