NCT05239221已完成1 期
A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZP-3601, a Synthetic Parathyroid Hormone Analog, in Healthy Subjects and in Subjects With Hypoparathyroidism
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
- 132
- 试验地点
- 2
- 主要终点
- Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of AZP-3601 following single and repeated administration in both healthy volunteers and patients with chronic hypoparathyroidism (cHP)
The protocol includes 3 parts:
- Part A: first-in-human single ascending dose (SAD) study in healthy volunteers
- Part B: multiple ascending dose (MAD) study with 2 weeks of treatment in healthy volunteers
- Part C: open-label MAD study with a total treatment duration of 3 months in patients with cHP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part C is open label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZP-3601
Experimental
subcutaneous (sc) administration once daily
干预措施: AZP-3601 (Drug)
Placebo (Parts A and B)
Placebo Comparator
subcutaneous (sc) administration once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 2 weeks in Part A and Part B, and up to 3 months in Part C
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
次要结局
- Observed Maximum Concentration (Cmax) - Part C(Day 1, Day 14, Day 28, Day 84)
- Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C(Day 1, Day 14, Day 28, Day 84)
- Calcium Corrected for Albumin - Part B(24 hours, Day 14)
- Serum Phosphate - Part A(24 hours)
- Observed Maximum Concentration (Cmax) - Part B(Day 1, Day 14)
- Observed Maximum Concentration (Cmax) - Part A(24 hours)
- Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A(24 hours)
- Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B(Day 1, Day 14)
- Calcium Corrected for Albumin - Part A(24 hours)
- Calcium Corrected for Albumin - Part C(Day 1, Day 14, Day 28 and Day 84)
- Serum Phosphate - Part B(Day 1, Day 14)
- Daily Dose of Oral Calcium and Active Vitamin D - Part C(Day 28 and Day 43)
- Serum Phosphate - Part C(Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2))
研究者
研究点 (2)
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