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Completed

NCT Number: NCT05732194

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site 1

Miami, Florida, 33014-3616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

ITI-333

Drug

ITI-333 oral solution

Placebo

Other

Matching placebo

Primary outcomes

  1. Pharmacokinetics: AUC0-tau

    Time frame: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose

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

  2. Pharmacokinetics: Cmax

    Time frame: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose

    Maximum plasma concentration of ITI-333 over a dosing interval

  3. Pharmacokinetics: Tmax

    Time frame: Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose

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

  4. Percentage of Subjects With Treatment-emergent Adverse Events

    Time frame: up to 30 days after last dose

  5. Change From Baseline in Systolic and Diastolic Blood Pressure

    Time frame: Baseline and Day 17

  6. Change From Baseline in SpO2

    Time frame: Baseline and Day 17

  7. Change From Baseline in ECG QTcF Interval

    Time frame: Baseline and Day 17

  8. Change From Baseline in Aspartate Aminotransferase

    Time frame: Baseline and Day 17

  9. Change From Baseline in Alanine Aminotransferase

    Time frame: Baseline and Day 17

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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