A Phase 1, Single Centre, Single-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Administration of Single Ascending Doses in Healthy Male Japanese Subjects
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
- 2
- 主要终点
- Description of the Safety and tolerability profile of MEDI9929
研究概览
简要总结
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
详细描述
This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investigated.
Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC) doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects.
Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts.
Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject will only participate in one cohort.
The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3 MEDI9929 (n=6) or placebo (n=2).
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
- 20 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.
- •Healthy Japanese male subjects aged 20 - 45 years age with a body mass index(BMI) between 18 - 27 kg/m2 at the time of screening
- •Sterilized males must be at least 1-year post vasectomy or non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85 (through Day 113 for cohort 3); It is highly recommended for both partners to use contraception, preferably one hormonal or intrauterine device (females) and one barrier method (males).
- •Were men who agree to use birth control for 4 months after the last dose of investigational product and to not donate sperm for 4 months after the last dose of investigational product
- •Able to comply with the requirements of the protocol
排除标准
- •Had history or evidence of a clinically significant disorder, condition, or disease (including cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic, or psychiatric), that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- •Any acute illness in the 14 days before Day 1
- •Had evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 30 days before randomization (eg, common cold, viral syndrome, flu-like symptoms), or a high risk, in the opinion of the investigator, for parasitic disease
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator
- •Has a history of anaphylaxis to another therapeutic monoclonal antibody or biologic therapy
研究组 & 干预措施
MEDI9929
Solution of MEDI9929, SC
干预措施: MEDI9929 (Drug)
Placebo
Placebo solution for MEDI9929, SC
干预措施: Placebo (Drug)
结局指标
主要结局
Description of the Safety and tolerability profile of MEDI9929
时间窗: 84 days for cohort 1/2, 112 days for cohort 3
To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.
次要结局
- Description of Pharmacokinetics profile for MEDI9929(84 days for cohort 1/2, 112 days for cohort 3)
- Description of Immunogenicity profile for MEDI9929(84 days for cohort 1/2, 112 days for cohort 3)