A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALXN2050 in Healthy Participants of Japanese Descent
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
研究概览
简要总结
This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.
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
- 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
- •Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
- •Participants must be of Japanese descent defined as:
- •First generation (born to 2 Japanese parents and 4 Japanese grandparents);
- •Born in Japan, and not have lived outside Japan for greater than 5 years;
- •Lifestyle, including diet, must not have significantly changed since leaving Japan.
- •Participants must be able to speak, read, and understand the Japanese and English languages.
- •Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
排除标准
- •History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- •History of significant multiple and/or severe allergies.
- •Any previous procedure that could alter absorption or excretion of orally administered drugs.
- •Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- •Body temperature ≥ 38.0°Celcius, at Screening or prior to the first dose of study intervention.
- •History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine users or smokers or a positive cotinine test at Screening.
- •Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
研究组 & 干预措施
Cohort 1: ALXN2050 (Dose 1)
Participants will receive ALXN2050 (Dose 1) as follows under fasting conditions: 120-milligrams (mg) single dose, 3-day washout, then 120-mg twice daily (BID) dosing.
干预措施: ALXN2050 (Drug)
Cohort 1: Placebo (Dose 1)
Participants will receive placebo (Dose 1) as follows under fasting conditions: 120-mg placebo single dose, 3-day washout, then 120-mg placebo BID dosing.
干预措施: Placebo (Drug)
Cohort 2: ALXN2050 (Dose 2)
Participants will receive ALXN2050 (Dose 2) as follows under fasting conditions: 180-mg single dose, 3-day washout, then 180-mg BID dosing.
干预措施: ALXN2050 (Drug)
Cohort 2: Placebo (Dose 2)
Participants will receive placebo (Dose 2) as follows under fasting conditions: 180-mg placebo single dose, 3-day washout, then 180-mg placebo BID dosing.
干预措施: Placebo (Drug)
结局指标
主要结局
Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
Cmax For Multiple-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
Tmax For Multiple-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
Number Of Participants With Treatment-emergent Adverse Events
时间窗: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
see Time Frame - defined
Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050
时间窗: Up to 72 hours postdose
see Time Frame - defined
次要结局
- Alternative Pathway Activity As Measured By Wieslab Assay(Up to 72 hours postdose)
- Complement Factor B Fraction b Levels(Up to 72 hours postdose)