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Inactive Indication- |
Drug Highest PhasePhase 2 |
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注射用GNP治疗急性失代偿性心力衰竭有效性和安全性的开放性、单臂设计的多中心IIa期临床研究
[Translation] An open-label, single-arm multicenter phase IIa clinical study on the efficacy and safety of injectable GNP in the treatment of acute decompensated heart failure
主要目的:探索注射用GNP在急性失代偿性心力衰竭患者中的有效性及安全性。
次要目的:
(1)探索注射用GNP在急性失代偿性心力衰竭患者中的药代动力学特征;
(2)探索注射用GNP在急性失代偿性心力衰竭患者中的免疫原性特征;
[Translation] Main purpose: To explore the effectiveness and safety of injectable GNP in patients with acute decompensated heart failure.
Secondary purpose:
(1) Explore the pharmacokinetic characteristics of injectable GNP in patients with acute decompensated heart failure;
(2) Explore the immunogenicity characteristics of injectable GNP in patients with acute decompensated heart failure;
评估GNP在中国健康成年受试者中单次给药的安全性、耐受性和药代动力学的I期临床研究
[Translation] Phase I clinical study evaluating the safety, tolerability and pharmacokinetics of single-dose GNPs in healthy Chinese adult subjects
主要目的:评估GNP在中国健康成年受试者单次递增给药的安全性和耐受性,并与安慰剂比较。
次要目的:(1)评估在健康受试者中GNP单次递增给药后药代动力学参数。(2)评估在健康受试者中GNP单次递增给药后的药效学特征。(3)评估在健康受试者中GNP单次递增给药后的免疫原性特征。
探索性目的:利用模型引导,探索药物剂量暴露与药物效应之间的量效关系。
[Translation] Main objective: To evaluate the safety and tolerability of a single ascending dose of GNP in healthy Chinese adult subjects and to compare it with placebo.
Secondary objectives: (1) To evaluate the pharmacokinetic parameters of GNP after a single ascending dose in healthy subjects. (2) To evaluate the pharmacodynamic characteristics of GNP after a single ascending dose in healthy subjects. (3) To evaluate the immunogenicity profile of GNP after a single ascending dose in healthy subjects.
Exploratory purpose: To use model guidance to explore the dose-response relationship between drug dose exposure and drug effect.
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