[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ENN0403 capsules after single and multiple administrations in healthy subjects
主要目的:评价中国健康成人受试者单次、多次口服ENN0403胶囊后的安全性和耐受性。
次要目的:评价中国健康成人受试者单次、多次口服ENN0403胶囊后的药代动力学特征。
探索性目的:评价中国健康成人受试者单次和多次给药后,ENN0403对血浆中靶点活性相关的PD影响。
[Translation] Primary objective: To evaluate the safety and tolerability of ENN0403 capsules after single and multiple oral administration in healthy Chinese adult subjects.
Secondary objective: To evaluate the pharmacokinetic characteristics of ENN0403 capsules after single and multiple oral administration in healthy Chinese adult subjects.
Exploratory objective: To evaluate the PD effects of ENN0403 on target activity in plasma after single and multiple administration in healthy Chinese adult subjects.