[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of PTT-501 in healthy volunteers
主要目的:评价 PTT-501 在健康受试者中单、多次不同剂量给药后的安全性和耐受性。
次要目的:评价 PTT-501 在健康受试者中单、多次不同 剂量给药后的 PK 特征。
探索性目的:评价 PTT-501 在健康受试者中单次不同剂量给药后的血药浓度对 Fridericia’s 公式按心率校正 的 QTc 间期的影响(C-QTc 研究)。探索食物对 PTT-501 PK 参数的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of PTT-501 after single and multiple doses in healthy subjects.
Secondary Objective: To evaluate the PK characteristics of PTT-501 after single and multiple doses in healthy subjects.
Exploratory Objective: To evaluate the effect of PTT-501 plasma concentrations after single and multiple doses on the heart rate-corrected QTc interval using Fridericia's formula (C-QTc study) in healthy subjects. To investigate the effect of food on PTT-501 PK parameters.