Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose, and a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with suitable veins for cannulation or repeated venepuncture
- •Pre-dose assessment judged without remarks by the investigator
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
排除标准
- •Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
- •Systolic blood pressure >140 mm Hg
- •Diastolic blood pressure >90 mm Hg
- •Heart rate ≤45 or >85 beats per minute
- •Lack of normal phenotype for BuChE (Butyrylcholinesterase)
研究组 & 干预措施
1
Intravenous solution given as a single ascending bolus dose
干预措施: AZD3043 (Drug)
2
Intravenous solution given as a single ascending bolus dose followed by a single infusion
干预措施: AZD3043 (Drug)
结局指标
主要结局
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
时间窗: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Assessment of vital signs data, heart rate, ECG
时间窗: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
次要结局
- PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma.(Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing)
- PK parameters for the metabolite (THRX 108893): Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, tmax, tlast, lz and t½lz in arterial and venous plasma.(Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing)