A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in systolic and diastolic blood pressure
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 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.
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 (SAO2) < 96% and < 12 breaths per min; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study
研究组 & 干预措施
Cohort 1: 0.03 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 1: 0.03 mg ITI-333 or placebo
干预措施: Placebo (Other)
Cohort 2: 0.09 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 2: 0.09 mg ITI-333 or placebo
干预措施: Placebo (Other)
Cohort 3: 0.25 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 3: 0.25 mg ITI-333 or placebo
干预措施: Placebo (Other)
Cohort 4: 0.75 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 4: 0.75 mg ITI-333 or placebo
干预措施: Placebo (Other)
Cohort 5: 2.25 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 5: 2.25 mg ITI-333 or placebo
干预措施: Placebo (Other)
Cohort 6: 6.75 mg ITI-333 or placebo
干预措施: ITI-333 (Drug)
Cohort 6: 6.75 mg ITI-333 or placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in systolic and diastolic blood pressure
时间窗: Up to Day 12
Change from baseline in hemoglobin
时间窗: Up to Day 12
Change from baseline in aspartate aminotransferase
时间窗: Up to Day 12
Change from baseline in alanine aminotransferase
时间窗: Up to Day 12
Percentage of subjects with treatment-emergent adverse events
时间窗: up to 30 days after last dose
Change from baseline in SAO2
时间窗: Up to Day 12
Change from baseline in ECG QT interval
时间窗: Up to Day 12
Change from baseline in white blood cell count
时间窗: Up to Day 12
次要结局
- Pharmacokinetics: T1/2(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: CL/F(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: Vz/F(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: AUC0-t(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: AUC0-inf(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: Cmax(predose and multiple timepoints up to 96 hours postdose)
- Pharmacokinetics: Tmax(predose and multiple timepoints up to 96 hours postdose)