drugset / Trial / NCT05732194
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Phase 1
Completed
32 enrolled
Intra-Cellular Therapies, Inc.
National Institute on Drug Abuse (NIDA) · collab
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2023-01-18
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ITI-333 | Unknown | 0.75 mg | Oral |
| Subject | ITI-333 | Unknown | 1.5 mg | Oral |
| Subject | ITI-333 | Unknown | 3 mg | Oral |
| Subject | ITI-333 | Unknown | 6 mg | Oral |
Indications
No indication recorded.