A Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, And Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.
详细描述
This is a First-time-in-human (FTiH) trial.
Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention.
The study will comprise:
- A Screening Period of maximum 28 days.
- A Treatment Period
- A Follow-up Period from Day 3 to Day 16
- An extended Follow-up Period from Day 17 to Day 61
Participants will be involved in this study for a maximum duration of 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •All females must have a negative pregnancy test at screening and on admission to the Clinical Unit.
- •Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
- •Have a body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m^2) inclusive and weigh at least 50 kilograms (kg) at screening.
排除标准
- •History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- •History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to screening as well as individuals with a smoking history of tobacco greater than 5 pack years.
- •History of alcohol or drug abuse within the past 2 years that, according to the PI, might affect assessments of safety or ability of participant to comply with all study requirements.
- •Any drug therapy within 7 days prior to Day 1 (except contraceptives, HRT, or a single use of acetaminophen, aspirin, antihistamine, or combination OTC product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, that is, have been taken for at least 30 days prior to enrollment, are not exclusionary.
- •Positive screen for drugs of abuse, alcohol, or cotinine at screening or on admission to the Clinical Unit.
- •Any abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- •Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longer) of the study intervention administration in this study. The period of exclusion begins one month after the final dose.
- •Receipt of any vaccine within 7 days prior to study intervention administration or planned receipt within 28 days after study intervention administration.
研究组 & 干预措施
AZD0292 Dose 1
Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.
干预措施: AZD0292 (Drug)
AZD0292 Dose 2
Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.
干预措施: AZD0292 (Drug)
AZD0292 Dose 3
Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.
干预措施: AZD0292 (Drug)
Placebo
Participants will receive matching placebo to AZD0292 as IV infusion on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
Number of Participants with Adverse Events of Special Interest (AESI)
时间窗: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
次要结局
- Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity)(From Dosing (Day 1) to end of the study (up to 13 weeks))
- Maximum Observed Drug Concentration (Cmax)(From Dosing (Day 1) to end of the study (up to 13 weeks))
- Number of Participants with Positive Anti-drug Antibodies (ADAs)(From Dosing (Day 1) to end of the study (up to 13 weeks))
- Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast)(From Dosing (Day 1) to end of the study (up to 13 weeks))