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

Phase 1 Completed 48 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 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.

Timeline

Start: 2020-12-23
Primary completion: 2021-08-23
Completion: 2021-08-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ITI-333	Unknown	0.03 mg	Oral
Subject	ITI-333	Unknown	0.09 mg	Oral
Subject	ITI-333	Unknown	0.25 mg	Oral
Subject	ITI-333	Unknown	0.75 mg	Oral
Subject	ITI-333	Unknown	2.25 mg	Oral
Subject	ITI-333	Unknown	6.75 mg	Oral

Indications

No indication recorded.