[Translation] A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety and tolerability of HRN77 tablets in healthy participants.
主要目的:
1.评价在健康参与者中单次、多次口服HRN77片后的安全性、耐受性;
2.评价食物对HRN77片药代动力学的影响。
次要目的:
1.评价在健康参与者中单次、多次口服HRN77片后的药代动力学特征;
2.评价HRN77片在健康参与者中的代谢与排泄特征;
3.评价HRN77片单次和多次给药后对健康参与者QTc间期的影响;
4.评价健康参与者在餐后状态下口服HRN77片的安全性和耐受性。
探索性目的:
探索在健康参与者中多次口服HRN77片后的药效学指标。
[Translation] Primary Objectives:
1. To evaluate the safety and tolerability of HRN77 tablets after single and multiple oral administrations in healthy participants;
2. To evaluate the effect of food on the pharmacokinetics of HRN77 tablets.
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of HRN77 tablets after single and multiple oral administrations in healthy participants;
2. To evaluate the metabolic and excretion characteristics of HRN77 tablets in healthy participants;
3. To evaluate the effect of single and multiple administrations of HRN77 tablets on the QTc interval in healthy participants;
4. To evaluate the safety and tolerability of HRN77 tablets administered orally in a postprandial state in healthy participants.
Exploratory Objective: To explore the pharmacodynamic parameters after multiple oral administrations of HRN77 tablets in healthy participants.