A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple 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
- 36
- 试验地点
- 1
- 主要终点
- Incidence of abnormal vital signs
研究概览
简要总结
This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.
Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.
Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women of non-child bearing potential
- •Aged 18 to 50 years, inclusive
- •Weigh more than 50 kg
- •Body Mass Index between 18 to 30 kg/m2
- •Healthy, in the opinion of the Principal Investigator
- •Able to understand and comply with the protocol requirements
排除标准
- •Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer
- •Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit
- •Poor venous access
- •History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics
- •Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder
- •History of cancer within 5 years of screening
- •History of drug abuse
- •Use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments
- •Any clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation
研究组 & 干预措施
MEDI0618
A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2)
干预措施: MEDI0618 (Drug)
Placebo
Histidine/histidine HCl, sucrose and polysorbate
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of abnormal vital signs
时间窗: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of abnormal laboratory parameters
时间窗: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of adverse events
时间窗: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
次要结局
- Time to maximum observed plasma concentration (Tmax) of MEDI0618(Day 1 to Day 113)
- Pre-dose trough concentration (Ctrough) of MEDI0618(Day 1 to Day 113)
- Anti-drug antibodies (ADA)(Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113)
- Maximum observed plasma concentration (Cmax) of MEDI0618(Day 1 to Day 113)
- The volume of plasma cleared of drug per unit time (CL) of MEDI0618(Day 1 to Day 113)
- Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618(Day 1 to Day 113)