A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 After Administration of Multiple Ascending Doses
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Description of the safety and tolerability profile of AZD2820 in terms of adverse events.
研究概览
简要总结
This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects.
详细描述
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses
- •Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture
- •Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- •Have a body mass index (BMI) between 27 and 40 kg/m2
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the stud
- •A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
- •Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820
- •Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator
研究组 & 干预措施
AZD2820
AZD2820 multiple injections
干预措施: AZD2820 (Drug)
Placebo for AZD2820
Placebo for AZD2820 multiple injections
干预措施: Placebo (Drug)
结局指标
主要结局
Description of the safety and tolerability profile of AZD2820 in terms of adverse events.
时间窗: From baseline, defined as day 1 of dosing, up to day 29
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of labolatory data ( clinical chemistry, haematology and urinalisys).
时间窗: From baseline, defined as one day prior first dose, up to day 28.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of vital signs ( pulse, systolic and diastolic blood preassure ( SBP, DBP and 24h ambulatory BP), body temperature).
时间窗: From baseline, defined as one day prior first dose, up to day 29.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of total immunoglobulin levels.
时间窗: From baseline, defined as one day prior first dose, up to day 44.
Number of subjects with immunoglobuline level outsite of reference range. No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of safety electrocardiogram (ECG).
时间窗: From baseline, defined as last pre dose measurement, up to day 28.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis
Description of the safety and tolerability profile of AZD2820 in terms of digital electrocardiogram (ECG).
时间窗: From baseline, defined as assessment at screening visit and day 1 of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. The QT correction factor will be based on the Fridericia's formula.
Description of the safety and tolerability profile of AZD2820 in terms of electroencephalography (EEG).
时间窗: From baseline, defined as mean value of the 10 minutes recording prior first dose up to 7th day of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of Columbia-Suicide Severity Rating Scale (C-SSRS).
时间窗: From baseline, defined as one day prior first dose, up to day 12th of dosing.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
Description of the safety and tolerability profile of AZD2820 in terms of skin pigmentation.
时间窗: From baseline, defined as one day before first dose, up to day 29.
No formal statistical test will be performed.
Description of the safety and tolerability profile of AZD2820 in terms of Penile erection (measured by Rigiscan).
时间窗: From baseline, defined as one day before first dose, up 12th day of dosing.
No formal statistical test will be performed.
Description of the safety and tolerability profile of AZD2820 in terms of physical examination.
时间窗: From baseline, defined as two days prior first dose, up to day 29.
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis.
次要结局
- Change in total caloric intake from baseline.(From baseline, defined as one day prior first dose to end of treatement which is day 15.)
- Description of the PK profile of AZD2820 in terms of Cmax, AUC(0-tau), AUC(0-t), AUC, (t1/2lz, h).(Day 1, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.)
- Description of PK profile of AZD2820 in terms of (Css,max, nmol/L), AUCss,(0-tau), (t1/2lz).(Day 7, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs.)