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COMPLETED
NCT05732194
PHASE1

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

ITI-333

ITI-333 oral solution

OTHER

Placebo

Matching placebo

Locations (1)

Clinical Site 1

Miami, Florida, United States