NCT01339182已完成1 期
A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Measurement of the IGF-1 levels for pharmacodynamics study
研究概览
简要总结
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age(yr)between 18 and 45
- •Body mass index(BMI)between 20 and 28
- •sign informed consent
排除标准
- •Known hypersensitivity to somatropin or any other components of the study drug
- •Organic lesion in heart, liver, kidney or any other major organs
- •History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
- •Alcoholic, smokers or drug abusers
- •Blood donation, or massive blood loss due to injury or surgery within 3 months
- •Other conditions which in the opinion of the investigator preclude enrollment into the study.
研究组 & 干预措施
Pegylated-Somatropin, 10mcg/kg
Experimental
干预措施: Pegylated-Somatropin (Drug)
Pegylated-Somatropin, 30mcg/kg
Experimental
干预措施: YPEG-Somatropin (Drug)
Pegylated-Somatropin, 60mcg/kg
Experimental
干预措施: YPEG-Somatropin (Drug)
Pegylated-Somatropin, 120mcg/kg
Experimental
干预措施: YPEG-Somatropin (Drug)
Pegylated-Somatropin, 200mcg/kg
Experimental
干预措施: YPEG-Somatropin (Drug)
结局指标
主要结局
Measurement of the IGF-1 levels for pharmacodynamics study
时间窗: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
次要结局
- Measuring the drug levels in blood samples(baseline, one week after initiation of the control drug and two weeks after initiation of the study drug)
- Measurement of IGFBP-3 levels for pharmacodynamic study(baseline, one week after initiation of the control drug and two weeks after initiation of the study drug)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy PatientsChemotherapy PatientsNCT01238562Xiamen Amoytop Biotech Co., Ltd.30
尚未招募
1 期
A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human SubjectsDiabetes Mellitus, Type 2NCT06422624Bostal Drug Delivery Co., Ltd14
已完成
1 期
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy VolunteersHerpes Simplex Virus InfectionNCT02346760United BioPharma15
已完成
1 期
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese SubjectsHealthy SubjectsNCT00705042Wyeth is now a wholly owned subsidiary of Pfizer60
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian ParticipantsHealthy VolunteersNCT05806359Bristol-Myers Squibb33