Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Safety and Tolerability (adverse events, local reactions, immunogenicity)
研究概览
简要总结
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •20 to 45 years old
- •Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
排除标准
- •Known history of hypersensitivity to human growth hormone (hGH)
- •Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
研究组 & 干预措施
ACP-001, dose-level 4
干预措施: Placebo (Drug)
ACP-001, dose-level 4
干预措施: Human Growth Hormone (Drug)
ACP-001, dose-level 1
干预措施: ACP-001 (TransCon PEG hGH) (Drug)
ACP-001, dose-level 1
干预措施: Placebo (Drug)
ACP-001, dose-level 1
干预措施: Human Growth Hormone (Drug)
ACP-001, dose-level 2
干预措施: ACP-001 (TransCon PEG hGH) (Drug)
ACP-001, dose-level 2
干预措施: Placebo (Drug)
ACP-001, dose-level 2
干预措施: Human Growth Hormone (Drug)
ACP-001, dose-level 3
干预措施: ACP-001 (TransCon PEG hGH) (Drug)
ACP-001, dose-level 3
干预措施: Placebo (Drug)
ACP-001, dose-level 3
干预措施: Human Growth Hormone (Drug)
ACP-001, dose-level 4
干预措施: ACP-001 (TransCon PEG hGH) (Drug)
结局指标
主要结局
Safety and Tolerability (adverse events, local reactions, immunogenicity)
时间窗: 0-42 days
Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
时间窗: 0-28 days
次要结局
未报告次要终点