A Double-Blind, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of ADX-914 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Q32 Bio Inc.
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of subjects with 12 Lead ECG changes
研究概览
简要总结
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
详细描述
Part 1 - SAD:
It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo.
It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used.
Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording
- •Men and women age 18-50
排除标准
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels greater than 1.5 x the upper limit of normal (ULN) at Screening or Day -
- •QT-interval measurements corrected according to the Fridericia rule (QTcF >450 msec) during controlled rest at Screening or family history of long QT syndrome.
- •Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the Investigator, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
- •A clinically significant vital signs abnormality, as judged by the Investigator, at Screening, or Day -
- •This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure <90 or >140 mmHg, (b) diastolic blood pressure <40 or >90 mmHg, or (c) heart rate <40 or >100 beats per minute.
研究组 & 干预措施
Experimental: Cohort 1:1 - 1:6 ADX-914
ADX-914 single SC dose
干预措施: ADX-914 (Drug)
Placebo Comparator: Cohort 1:1 - 1:6 placebo
Placebo single SC dose
干预措施: Placebo (Drug)
Experimental: Cohort 2:1- 2:3
ADX-914 multiple SC dose once every 2 weeks for 6 weeks
干预措施: ADX-914 (Drug)
Placebo Comparator: Cohort 2:1- 2:3
Placebo multiple SC dose once every 2 weeks for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with 12 Lead ECG changes
时间窗: Screening to end of study, up to 18 weeks
Change in 12-lead ECG parameters from baseline to end of study
Number of subjects with Heart rate changes
时间窗: Screening to end of study, up to 18 weeks
Listing and change from baseline to end of study
Number of subjects with Physical exam findings
时间窗: Screening to end of study, up to 18 weeks
Listing of clinically significant changes in PE findings
Number of subjects with Clinical safety lab changes
时间窗: Screening to end of study, up to 18 weeks
Listing and change from baseline to end of study
Number of subjects with adverse events
时间窗: Screening to end of study, up to 18 weeks
Listing and summary of AE incidence
Number of subjects with Systolic blood pressure changes
时间窗: Screening to end of study, up to 18 weeks
Listing and change from baseline to end of study
次要结局
- Maximum observed plasma concentration, Cmax(Predose to Day 91 (SAD) and Day 127 (MAD))
- Time to reach maximum observed plasma concentration, Tmax(Predose to Day 91 (SAD) and Day 127 (MAD))
- Area Under the plasma concentration time curve, AUC(Predose to Day 91 (SAD) and Day 127 (MAD))