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

Intra-Cellular Therapies

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: ITI-333

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04934124

1UG3DA047699-01 (U.S. NIH Grant/Contract)

ITI-333-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 (SAO2) < 96% and < 12 breaths per min; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Cohort 1: 0.03 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333

Cohort 2: 0.09 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333

Cohort 3: 0.25 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333

Cohort 4: 0.75 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333

Cohort 5: 2.25 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333

Cohort 6: 6.75 mg ITI-333 or placebo

Experimental group

Treatment:

Other: Placebo

Drug: ITI-333