A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 12-Lead Electrocardiogram
研究概览
简要总结
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.
详细描述
This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers.
This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.
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 (Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women of non-childbearing potential aged 18 to 55 years
- •Normal 12-lead ECG at screening and on day of dosing
- •Physical examinations with no significant findings at screening
- •Be able to understand and comply with protocol requirements
排除标准
- •Participation in another clinical study with an investigational product (IP) within half-lives of the IP or 3 months, whichever is longer, prior to screening
- •Requires treatment with another biological therapeutic agent
- •Inability to comply with study-related requirements
- •History of severe allergy or hypersensitivity reactions
- •History of significant psychiatric disorder
- •Presence of any clinically significant illness
- •History of cancer
- •Any clinically important abnormality physical examination, vital signs, ECG or laboratory test
研究组 & 干预措施
Dose Level 1
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 1
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 2
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 2
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 3
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 3
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 4
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 4
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 5
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 5
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 6
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 6
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 7
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 7
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 8
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 8
MEDI0618 or placebo
干预措施: Placebo (Drug)
Dose Level 9
MEDI0618 or placebo
干预措施: MEDI0618 (Drug)
Dose Level 9
MEDI0618 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
12-Lead Electrocardiogram
时间窗: Up to 85 days
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Clinical Chemistry
时间窗: Up to 85 days
Measurement of Albumin, Protein, Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, Bilirubin, Calcium, Creatine phosphokinase, C-reactive protein, Glucose, Blood urea nitrogen, Phosphate, Potassium, Sodium, Chloride and Bicarbonate
Haematology
时间窗: Up to 85 days
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Thyroid Function
时间窗: Up to 85 days
Measurement of Thyroid-stimulating hormone and free thyroxine
Renal Function
时间窗: Up to 85 days
Measurement of Glomerular filtration rate
Urinalysis
时间窗: Up to 85 days
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Physical Examination
时间窗: Up to 85 days
General physical examination
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to 85 days
Adverse Events
Body Weight
时间窗: Up to 85 days
Weight in kg
Incidence of Treatment-Emergent Serious Adverse Events
时间窗: Up to 85 days
Serious Adverse Events
Vital Signs
时间窗: Up to 85 days
Blood pressure in mm Hg
Height
时间窗: Up to 85 days
Height in meters Height and weight will be combined to report BMI in kg/m\^2
次要结局
- Time to maximum concentration (tmax)(Up to 85 days)
- Terminal half-life(Up to 85 days)
- Bioavailability(Up to 85 days)
- Area under the concentration versus time curve (AUC)(Up to 85 days)
- Peak plasma concentration (Cmax)(Up to 85 days)