Phase 1
N=32
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05732194 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Pharmacokinetics: AUC0-tau — 94.927; 107.30; 294.48; 1059.5 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ITI-333 (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: AUC0-tau |
94.927; 107.30; 294.48; 1059.5 | — |
| PRIMARY Pharmacokinetics: Cmax |
8.810; 16.75; 41.60; 117.3 | — |
| PRIMARY Pharmacokinetics: Tmax |
1.500; 1.000; 1.000; 1.000 | — |
| PRIMARY Percentage of Subjects With Treatment-emergent Adverse Events |
0; 1; 4; 2; 4 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic Blood Pressure |
-2.3; 2.3; 10.7; 5.5; 3.8; -0.3 | — |
| PRIMARY Change From Baseline in SpO2 |
0.3; 1.5; 0.5; -0.2; 0.6 | — |
| PRIMARY Change From Baseline in ECG QTcF Interval |
-12.5; -4.3; -0.3; -8.7; -4.6 | — |
| PRIMARY Change From Baseline in Aspartate Aminotransferase |
-0.8; -1.5; -3.7; 2.0; -0.3 | — |
| PRIMARY Change From Baseline in Alanine Aminotransferase |
0.0; 2.8; 1.5; 4.3; 2.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05732194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.