Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
- Registration Number
- NCT05732194
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days ITI-333 - Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days Placebo - Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days Placebo - Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days Placebo - Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days Placebo - Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days ITI-333 - Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days ITI-333 - Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days ITI-333 -
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Tmax Day 14 Time of maximum plasma concentration of ITI-333 and its metabolites over a dosing interval
Percentage of subjects with treatment-emergent adverse events up to 30 days after last dose Change from baseline in systolic and diastolic blood pressure Day 17 Change from baseline in SpO2 Day 17 Change from baseline in ECG QT interval Day 17 Change from baseline in aspartate aminotransferase Day 17 Change from baseline in alanine aminotransferase Day 17 Pharmacokinetics: AUC0-tau Day 14 Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Pharmacokinetics: Cmax Day 14 Maximum plasma concentration of ITI-333 and its metabolites over a dosing interval
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Site 1
🇺🇸Miami, Florida, United States