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Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Sponsor: Intra-Cellular Therapies, Inc.
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2023-01-18
Completion Date
2023-09-01
Last Updated
2026-06-09
Healthy Volunteers
Yes
Conditions
Interventions
ITI-333
ITI-333 oral solution
Placebo
Matching placebo
Locations (1)
Clinical Site 1
Miami, Florida, United States