NCT06093542已完成1 期
A Randomised, Single-blind, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
详细描述
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously.
The study will comprise of:
- A screening period of 28 days.
- Randomization on Day 1.
- A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57.
- A follow-up period of 10 week after last dose of study intervention.
- The total duration of the study will be 23 weeks
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
The study is single blind where the study site staff including the investigator will remain blinded during the clinical conduct of a given cohort.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participants must have suitable veins for cannulation.
- •Females must be of non-childbearing potential.
- •Males and females must adhere to the contraception methods.
- •Have a Body mass index between 18 and 30 kg/m2 inclusive.
排除标准
- •History of any clinically significant disease or disorder in the investigator's opinion.
- •History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure or trauma.
- •Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography.
- •Any clinically significant cardiovascular event.
- •Participants with known autoimmune disease or on-treatment with immune-modulatory drugs.
- •Any positive result at the Screening Visit for serum Hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency virus.
- •Confirmed COVID-19 infection during screening as per local guidelines.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- •Use of any prescribed or nonprescribed medication.
- •History of major bleed or high-risk of bleeding diathesis.
- •Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- •Participants who have previously received AZD7503 or any investigational drug targeting HSD17B
- •Vulnerable participants.
研究组 & 干预措施
AZD7503
Experimental
Participants will subcutaneously receive AZD7503.
干预措施: AZD7053 (Drug)
Placebo
Placebo Comparator
Participants will subcutaneously receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)
The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
次要结局
- Maximum plasma drug concentration (Cmax)(Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59)
- Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)(Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59)
- Area under plasma concentration-time curve from time 0 to infinity (AUCinf)(Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59)
- Area under plasma concentration-time curve during a dosing interval (AUCtau)(Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59)
- Amount of analyte excreted into the urine (Ae)(Day 1, Day 2, Day 3, Day 58, and Day 59)
- Fraction of the dose excreted unchanged in urine (Fe)(Day 1, Day 2, Day 3, Day 58, and Day 59)
- Plasma concentration of AZD7503(Day 1, Day 2, Day 3, Day 58, and Day 59)
- Plasma concentration of unconjugated antisense oligonucleotide (ASO)(Day 1, Day 2, Day 3, Day 58, and Day 59)
研究者
研究点 (1)
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