/ Not yet recruitingPhase 1 一项评价注射用GRK-006在健康受试者中的随机、双盲、安慰剂对照的单次及多次给药剂量递增的安全性、耐受性和药代动力学的I期临床试验
[Translation] A randomized, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple dose escalation of GRK-006 for injection in healthy subjects
主要目的:评价注射用GRK-006在健康成年受试者中单次、多次给药的安全性和耐受性;
次要目的:评价注射用GRK-006在健康成年受试者中单次、多次给药的药代动力学(Pharmacokinetic,PK)特征,及安全性和PK暴露相关性,为后续临床研究提供剂量选择依据;
探索性目的:探索注射用GRK-006对经校正的QT间期和其它ECG参数(心率、PR间期、RR间期和QRS持续时间)的影响;
探索GRK-006在人体血浆的代谢物谱。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple administrations of GRK-006 for injection in healthy adult subjects;
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of single and multiple administrations of GRK-006 for injection in healthy adult subjects, as well as the correlation between safety and PK exposure, and to provide a basis for dose selection for subsequent clinical studies;
Exploratory objective: To explore the effects of GRK-006 for injection on the corrected QT interval and other ECG parameters (heart rate, PR interval, RR interval and QRS duration);
Explore the metabolite profile of GRK-006 in human plasma.
/ Not yet recruitingPhase 1 一项评价GRK-008片在健康受试者中的随机、双盲、安慰剂对照的单次及多次给药剂量递增的安全性、耐受性和药代动力学的I期临床试验
[Translation] A randomized, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of GRK-008 tablets in healthy subjects with single and multiple dose escalation
主要目的:考察健康受试者单次、多次口服GRK-008片的安全性和耐受性。
次要目的:评价GRK-008片在健康成年受试者中单次、多次给药的药代动力学(Pharmacokinetic,PK)特征,及安全性和PK暴露相关性,为后续临床研究提供剂量选择依据。
探索性目的:探索GRK-008对经校正的QT间期和其它ECG参数(心率、PR间期、RR间期和QRS持续时间)的影响;探索GRK-008在人体血浆的代谢物谱。
[Translation] Primary objective: To investigate the safety and tolerability of single and multiple oral administration of GRK-008 tablets in healthy subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of single and multiple administration of GRK-008 tablets in healthy adult subjects, as well as the correlation between safety and PK exposure, and to provide a basis for dose selection for subsequent clinical studies.
Exploratory objective: To explore the effects of GRK-008 on the corrected QT interval and other ECG parameters (heart rate, PR interval, RR interval, and QRS duration); to explore the metabolite profile of GRK-008 in human plasma.
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