[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and food effect of BPYT-01 capsules after a single dose in healthy subjects
主要目的:
评价中国健康受试者单次口服BPYT-01胶囊后的安全性和耐受性。
次要目的:
1) 评价中国健康受试者单次口服BPYT-01胶囊后的药代动力学特征。
2) 评估食物对BPYT-01胶囊安全性、耐受性和药代动力学特征的影响。
[Translation] Primary objective:
To evaluate the safety and tolerability of BPYT-01 capsules after a single oral administration in healthy Chinese subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of BPYT-01 capsules after a single oral administration in healthy Chinese subjects.
2) To evaluate the effect of food on the safety, tolerability and pharmacokinetic characteristics of BPYT-01 capsules.