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

NCT05732194 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: ITI-333-0021UG3DA047699-021UG3DA047699
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics: AUC0-tau

  Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval

  Day 14

• Pharmacokinetics: Cmax

  Maximum plasma concentration of ITI-333 over a dosing interval

  Day 14

• Pharmacokinetics: Tmax

  Time of maximum plasma concentration of ITI-333 over a dosing interval

  Day 14

• Percentage of Subjects With Treatment-emergent Adverse Events

  up to 30 days after last dose

• Change From Baseline in Systolic and Diastolic Blood Pressure

  Baseline and Day 17

• Change From Baseline in SpO2

  Baseline and Day 17

• Change From Baseline in ECG QTcF Interval

  Baseline and Day 17

• Change From Baseline in Aspartate Aminotransferase

  Baseline and Day 17

• Change From Baseline in Alanine Aminotransferase

  Baseline and Day 17

Study Arms (4)

Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Interventions

ITI-333 DRUG

ITI-333 oral solution

Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days; Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days; Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days; Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days

Placebo OTHER

Matching placebo

Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days; Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days; Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days; Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects between 18 and 45 years old (inclusive);
• BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
• Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.

You may not qualify if:

• Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
• Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \< 96% and respiratory rate \< 12 breaths per min;
• History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
• CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Clinical Site 1

Miami, Florida, 33014-3616, United States

Location

Results Point of Contact

• Title: ITI Clinical Trials
• Organization: Intra-Cellular Therapies, Inc.

ITCIClinicalTrials@itci-inc.com

6464409333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential ascending doses. Parallel (active, placebo) within each cohort

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: January 18, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)