Trials / Completed
CompletedNCT05732194
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Intra-Cellular Therapies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITI-333 | ITI-333 oral solution |
| OTHER | Placebo | Matching placebo |
Timeline
- Start date
- 2023-01-18
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2023-02-16
- Last updated
- 2026-03-31
- Results posted
- 2026-03-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05732194. Inclusion in this directory is not an endorsement.