[Translation] A Phase Ia clinical trial evaluating the tolerability and pharmacokinetics of a single-center, randomized, double-blind, placebo-controlled single-dose dose of OTB-658 in healthy subjects
主要目的:
评价OTB-658在健康受试者中多剂量、单次给药的安全性、耐受性。
次要目的: 评价进食对健康受试者单次口服OTB-658体内药代动力学的影响。
评价OTB-658在健康受试者中多剂量、单次给药的药代动力学特征。
评价OTB-658在健康受试者体内的药物代谢转化。
[Translation] main purpose:
To evaluate the safety and tolerability of OTB-658 in healthy subjects with multiple doses and single administration.
Secondary Objectives: To evaluate the effect of food intake on the in vivo pharmacokinetics of a single oral dose of OTB-658 in healthy subjects.
To evaluate the pharmacokinetics of OTB-658 in healthy subjects with multiple doses, single administration.
To evaluate the drug metabolism transformation of OTB-658 in healthy subjects.