NCT00778518已完成2 期
Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ambrx, Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Temporal profiling of circulating IGF-1 levels.
研究概览
简要总结
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
详细描述
The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-30 years old
- •GHD of childhood onset
- •completed growth
- •IGF-1 <=2SDS
- •rhGH treatment naive
- •hGH levels below cut-off
排除标准
- •History of malignancy or intracranial tumors
- •ECG abnormality
- •hepatic dysfunction
- •renal impairment
- •major medical conditions
- •inadequate T4
- •positive for HBV, HCV, or HIV
- •alcohol or drug abuse
研究组 & 干预措施
1
Active Comparator
low dose
干预措施: ARX201 (Drug)
2
Active Comparator
Medium dose
干预措施: ARX201 (Drug)
3
Active Comparator
High Dose
干预措施: ARX201 (Drug)
结局指标
主要结局
Temporal profiling of circulating IGF-1 levels.
时间窗: 3 period
次要结局
- Body composition measurements at start of study and end of study(6 months)
研究者
研究点 (1)
Loading locations...
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