NCT07612813招募中1 期
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
详细描述
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- •Healthy Japanese participants with no clinically significant concomitant diseases or medications.
排除标准
- •Known hypersensitivity to any component of the study intervention.
- •Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
- •Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- •AST or ALT above 1.5 × ULN at screening.
- •Estimated glomerular filtration rate < 90 mL/min/1.73 m
- •Hemoglobin or platelet count below the lower limit of normal at screening.
- •White blood cell counts outside normal reference ranges.
- •History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
- •Any clinically significant abnormalities on 12-lead ECG at screening,
- •Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
- •Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
- •Any condition that has the potential to increase clearance of the study intervention.
- •Blood donation or collection as follows:
- •400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- •200 mL whole blood donation within 4 weeks prior to study drug administration.
- •Apheresis donation within 2 weeks prior to study drug administration.
- •Absence of suitable veins for blood sampling and administration of study intervention.
- •Any other condition that would compromise the safety of the participants.
- •Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
- •Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
研究组 & 干预措施
Cohort 2 (AZD7760 Dose B)
Experimental
Participants receive an IV infusion of AZD7760 Dose B on Day 1.
干预措施: AZD7760 (Drug)
Pooled Placebo
Placebo Comparator
Participants receive an IV infusion of matching placebo on Day 1.
干预措施: Placebo (Other)
Cohort 1 (AZD7760 Dose A)
Experimental
Participants receive an IV infusion of AZD7760 Dose A on Day 1.
干预措施: AZD7760 (Drug)
研究者
研究点 (1)
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