A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: AUC0-tau
研究概览
简要总结
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between 18 and 45 years old (inclusive);
- •BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
- •Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.
排除标准
- •Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
- •Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) < 96% and respiratory rate < 12 breaths per min;
- •History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
- •CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.
研究组 & 干预措施
Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days
干预措施: Placebo (Other)
Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days
干预措施: ITI-333 (Drug)
Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days
干预措施: ITI-333 (Drug)
Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days
干预措施: Placebo (Other)
Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days
干预措施: Placebo (Other)
Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days
干预措施: ITI-333 (Drug)
Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days
干预措施: Placebo (Other)
Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days
干预措施: ITI-333 (Drug)
结局指标
主要结局
Pharmacokinetics: AUC0-tau
时间窗: Day 14
Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Pharmacokinetics: Cmax
时间窗: Day 14
Maximum plasma concentration of ITI-333 over a dosing interval
Pharmacokinetics: Tmax
时间窗: Day 14
Time of maximum plasma concentration of ITI-333 over a dosing interval
Percentage of subjects with treatment-emergent adverse events
时间窗: up to 30 days after last dose
Change From Baseline in ECG QTcF Interval
时间窗: Baseline and Day 17
Change From Baseline in SpO2
时间窗: Baseline and Day 17
Change From Baseline in Aspartate Aminotransferase
时间窗: Baseline and Day 17
Change From Baseline in Alanine Aminotransferase
时间窗: Baseline and Day 17
Pharmacokinetics: AUC0-tau
时间窗: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Pharmacokinetics: Cmax
时间窗: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Maximum plasma concentration of ITI-333 over a dosing interval
Pharmacokinetics: Tmax
时间窗: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Time of maximum plasma concentration of ITI-333 over a dosing interval
Percentage of Subjects With Treatment-emergent Adverse Events
时间窗: up to 30 days after last dose
Change From Baseline in Systolic and Diastolic Blood Pressure
时间窗: Baseline and Day 17
次要结局
未报告次要终点