Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Completed · Phase 1 · NCT05732194
Conditions: Healthy Volunteers
At a glance
- Research payments reported, 2025
- $338
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 32
About the trial
- Sponsor
- Intra-Cellular Therapies, Inc. (with National Institute on Drug Abuse (NIDA))
- Tested
- ITI-333 (drug), Placebo (other)
- Dates
- Started 2023-01-18; completion 2023-09-01
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-06-09. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Iti, Inc. (d/b/a Intra-cellular Therapies, Inc.) reported $338 in research payments for this study in 2025 (1 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Pharmacology of Miami LLC $338
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.