A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC
研究概览
简要总结
This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design
详细描述
This study will be conducted in subjects with established Parkinson's disease in 2 parts.
Part A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts
Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in subjects with established Parkinson's disease experiencing regular OFF episodes
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)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of Parkinson's Disease
- •Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m
- •Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
排除标准
- •Any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.
- •History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss
研究组 & 干预措施
A-1a
Part A, Arm 1 (active), Dose 1 (009-A1)
干预措施: 009-A1 (Drug)
A-2a
Part A, Arm 2 (active), Dose 2 (009-A2)
干预措施: 009-A2 (Drug)
A-3a
Part A, Arm 3 (active), Dose 3 (009-A3)
干预措施: 009-A3 (Drug)
A-0p
Part A, placebo comparator in all 3 arms, placebo dose (009-A0)
干预措施: 009-A0 (Drug)
B-1 (009-B3 -> 009-B0)
Crossover (active to placebo)
干预措施: 009-B1 (active --> placebo) crossover (Drug)
B-1 (009-B0 -> 009-B3)
Crossover (placebo to active)
干预措施: 009-B2 (placebo --> active) crossover (Drug)
结局指标
主要结局
A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC
时间窗: 6 days
Dose proportionality of inhaled Staccato apomorphine AUC across all 3 doses during Days 1-5 and multiple daily dosing (all 3 doses q 2 hr per day) on Day 6 using a power model \[regression of log(AUC) versus log(dose)\] in subjects with established Parkinson's disease
B1 - Effect on MDS-UPDRS in Parkinson's disease OFF periods
时间窗: 2 days
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in subjects with established Parkinson's disease experiencing regular OFF episodes.
B2 - Effect on Physician Disease State Assessment in Parkinson's disease OFF periods
时间窗: 2 days
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Physician Disease State Assessment in subjects with established Parkinson's disease experiencing regular OFF episodes.
B3 - Effect on Patient Assessment of ON/OFF in Parkinson's disease OFF periods
时间窗: 2 days
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on Patient Assessment of ON/OFF in subjects with established Parkinson's disease experiencing regular OFF episodes.
次要结局
未报告次要终点