单中心、随机、双盲及安慰剂对照评价ENN0403胶囊在健康受试者中单次、多次给药后人体安全性、耐受性及药代、药效动力学I期临床研究
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。
Single-center, randomized, double-blind and placebo-controlled evaluation of ENN0403 capsules in healthy subjects after single and multiple administration of human safety, tolerability, pharmacokinetics, and pharmacodynamics Phase I clinical study
A Phase 1, first-in-human, 2-part, randomized, double-blind, placebo-controlled, parallel-group, single ascending dose and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ENN0403 in healthy adult subjects.
100 项与 ENN-0403 相关的专利(医药)