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.
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetics: AUC0-tau
Timeframe: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Pharmacokinetics: Cmax
Timeframe: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Pharmacokinetics: Tmax
Timeframe: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose
Percentage of Subjects With Treatment-emergent Adverse Events
Timeframe: up to 30 days after last dose
Change From Baseline in Systolic and Diastolic Blood Pressure
Timeframe: Baseline and Day 17
Change From Baseline in SpO2
Timeframe: Baseline and Day 17
Change From Baseline in ECG QTcF Interval
Timeframe: Baseline and Day 17
Change From Baseline in Aspartate Aminotransferase
Timeframe: Baseline and Day 17
Change From Baseline in Alanine Aminotransferase
Timeframe: Baseline and Day 17