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Clinical Trials associated with PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.) / Active, not recruitingPhase 2/3 评价聚乙二醇化重组人生长激素注射液安全性和有效性的随机、开放、多中心的Ⅱ、Ⅲ期临床合并研究
[Translation] A randomized, open, multicenter phase II and III clinical study to evaluate the safety and efficacy of pegylated recombinant human growth hormone injection
1、进行剂量探索,确定PEG-rhGH治疗GHD患儿的最佳给药方案; 2、评价PEG-rhGH治疗GHD患儿的安全性和有效性。
[Translation] 1. Conduct dose exploration to determine the optimal dosing regimen for PEG-rhGH in children with GHD; 2. Evaluate the safety and efficacy of PEG-rhGH in children with GHD.
聚乙二醇化重组人生长激素注射液剂量递增的健康受试者安全耐受性、药代药效动力学Ⅰ期临床试验
[Translation] Phase I clinical trial of safety, tolerability, pharmacokinetics and pharmacodynamics of PEGylated recombinant human growth hormone injection in healthy subjects with increasing doses
1、研究健康成年受试者单次皮下注射PEG-rhGH的安全耐受性,确定其安全剂量范围。为确定人体药代动力学研究剂量以及II期临床试验给药方案提供依据。 2、研究健康成年男性受试者皮下注射不同剂量的PEG-rhGH的药代动力学,了解该药在人体内吸收、分布、消除的规律,并与rhGH比较以考察药物在人体内的PK-PD特征,为II期临床试验制定合理的给药方案提供依据。
[Translation] 1. Study the safety and tolerance of a single subcutaneous injection of PEG-rhGH in healthy adult subjects and determine its safe dosage range. Provide a basis for determining the human pharmacokinetic study dose and the dosing regimen for Phase II clinical trials. 2. Study the pharmacokinetics of different doses of PEG-rhGH injected subcutaneously in healthy adult male subjects to understand the absorption, distribution, and elimination of the drug in the human body, and compare it with rhGH to examine the PK-PD characteristics of the drug in the human body, and provide a basis for formulating a reasonable dosing regimen for Phase II clinical trials.
100 Clinical Results associated with PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Translational Medicine associated with PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Patents (Medical) associated with PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Deals associated with PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.)