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Drug Highest PhasePhase 2 |
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评价DH001在健康成年受试者单次及多次口服给药后的安全性、耐受性、药代动力学的Ⅰ期临床试验
[Translation] Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of DH001 after single and multiple oral administration in healthy adult subjects
本试验分为 2 项研究开展, 每项研究试验目的如下:
研究 1:
主要目的: 评价DH001 单次口服给药后的安全性和耐受性。
次要目的: 评价DH001 单次口服给药后的药代动力学特征。
研究 2:
主要目的: 评价DH001 多次口服给药后的安全性和耐受性。
次要目的: 评价DH001 多次口服给药后的药代动力学特征。
[Translation] This trial was divided into 2 studies, and the purpose of each study is as follows:
Study 1:
Primary purpose: To evaluate the safety and tolerability of DH001 after a single oral administration.
Secondary purpose: To evaluate the pharmacokinetic characteristics of DH001 after a single oral administration.
Study 2:
Primary purpose: To evaluate the safety and tolerability of DH001 after multiple oral administration.
Secondary purpose: To evaluate the pharmacokinetic characteristics of DH001 after multiple oral administration.
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