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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2021-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: 0.03 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Cohort 2: 0.09 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Cohort 3: 0.25 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Cohort 4: 0.75 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Cohort 5: 2.25 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Cohort 6: 6.75 mg ITI-333 or placebo

Group Type EXPERIMENTAL

ITI-333

Intervention Type DRUG

ITI-333 oral solution

Placebo

Intervention Type OTHER

Matching placebo

Interventions

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ITI-333

ITI-333 oral solution

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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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;

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes