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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05732194

Enrollment

Registered

2023-02-16

Start date

2023-01-18

Completion date

2023-09-01

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGITI-333

ITI-333 oral solution

OTHERPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics: AUC0-tau	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
Pharmacokinetics: Cmax	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
Pharmacokinetics: Tmax	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
Percentage of Subjects With Treatment-emergent Adverse Events	up to 30 days after last dose	—
Change From Baseline in Systolic and Diastolic Blood Pressure	Baseline and Day 17	—
Change From Baseline in SpO2	Baseline and Day 17	—
Change From Baseline in ECG QTcF Interval	Baseline and Day 17	—
Change From Baseline in Aspartate Aminotransferase	Baseline and Day 17	—
Change From Baseline in Alanine Aminotransferase	Baseline and Day 17	—

Countries

United States

Baseline characteristics

Characteristic	—
Age, Continuous	30.3 years STANDARD_DEVIATION 8.48
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	26 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 6	0 / 6	0 / 6	0 / 8
other Total, other adverse events	0 / 6	1 / 6	4 / 6	2 / 6	4 / 8
serious Total, serious adverse events	0 / 6	0 / 6	0 / 6	0 / 6	0 / 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026