A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
研究概览
简要总结
This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- •Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
- •Female participant of nonchildbearing potential.
- •Male participant agreed to abstinence or use of a highly effective form of contraception.
排除标准
- •Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •Had any condition possibly affecting drug absorption.
- •Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
- •Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
- •Had participated in a clinical study within 30 days prior to first study drug administration
- •Had clinically significant laboratory abnormalities,
- •Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
- •Had a clinically significant history of drug allergy.
研究组 & 干预措施
Cohort 2: 80 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: ALXN2050 (Drug)
Cohort 2: 80 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 1: 40 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: ALXN2050 (Drug)
Cohort 1: 40 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 3: 120 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: ALXN2050 (Drug)
Cohort 3: 120 mg ALXN2050/Placebo
Participants randomized to receive ALXN2050 or placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
时间窗: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
时间窗: Day 1 through Day 42
Number Of Participants Experiencing Serious Adverse Events
时间窗: Day 1 through Day 42
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
时间窗: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
时间窗: Day 1 through Day 42
次要结局
- Maximum Plasma Concentration (Cmax) Of ALXN2050(Up to 144 hours postdose)
- Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050(Up to 144 hours postdose)
- Alternative Pathway (AP) Activity As Measured By Wieslab Assay(Up to 144 hours postdose)
- Plasma Bb Fragment Of Complement Factor B Concentration Over Time(Up to 144 hours postdose)
- Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050(Up to 144 hours postdose)