At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled / 32 target
Drug / intervention
ITI-333 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating ITI-333 and Placebo for Healthy Volunteers. Completed, enrolled 32 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartJan 2023
First PostedFeb 2023
Primary CompletionSep 2023
TodayJul 2026
First PostedFeb 16, 2023
Enrollment StartJan 18, 2023
Primary CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.4 years ago
Arms & Interventions
Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 daysexperimental
Drug: ITI-333Other: Placebo
Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 daysexperimental
Drug: ITI-333Other: Placebo
Cohort 3: 3 mg ITI-333 or placebo once daily for 14 daysexperimental
Drug: ITI-333Other: Placebo
Cohort 4: 6 mg ITI-333 or placebo once daily for 14 daysexperimental
Drug: ITI-333Other: Placebo
Interventions
ITI-333drug
ITI-333 oral solution
Placeboother
Matching placebo