Trial Outcomes & Findings for Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers (NCT NCT05732194)
NCT ID: NCT05732194
Last Updated: 2026-03-31
Results Overview
Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 14
Results posted on
2026-03-31
Participant Flow
Participant milestones
| Measure |
0.75 mg ITI-333
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
6 mg ITI-333 oral solution once daily for 14 days
|
Pooled Placebo
Matching placebo once daily for 14 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 7.66 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 8.48 • n=28 Participants
|
37.2 years
STANDARD_DEVIATION 7.33 • n=10 Participants
|
28.7 years
STANDARD_DEVIATION 11.24 • n=16 Participants
|
34.1 years
STANDARD_DEVIATION 8.95 • n=12 Participants
|
32.8 years
STANDARD_DEVIATION 8.77 • n=49 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=16 Participants
|
5 Participants
n=12 Participants
|
17 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=12 Participants
|
15 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=4 Participants
|
6 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=12 Participants
|
26 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: The PK Population included all subjects who had at least one evaluable estimate of a PK parameter.
Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Outcome measures
| Measure |
Pooled Placebo
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Pharmacokinetics: AUC0-tau
|
—
|
94.927 h*ng/mL
Standard Deviation 77.467
|
107.30 h*ng/mL
Standard Deviation 57.596
|
294.48 h*ng/mL
Standard Deviation 161.01
|
1059.5 h*ng/mL
Standard Deviation 185.18
|
PRIMARY outcome
Timeframe: Day 14Population: The PK Population included all subjects who had at least one evaluable estimate of a PK parameter.
Maximum plasma concentration of ITI-333 over a dosing interval
Outcome measures
| Measure |
Pooled Placebo
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax
|
—
|
8.810 ng/mL
Standard Deviation 3.644
|
16.75 ng/mL
Standard Deviation 6.142
|
41.60 ng/mL
Standard Deviation 16.29
|
117.3 ng/mL
Standard Deviation 27.13
|
PRIMARY outcome
Timeframe: Day 14Population: The PK Population included all subjects who had at least one evaluable estimate of a PK parameter.
Time of maximum plasma concentration of ITI-333 over a dosing interval
Outcome measures
| Measure |
Pooled Placebo
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax
|
—
|
1.500 h
Interval 1.0 to 1.5
|
1.000 h
Interval 1.0 to 1.5
|
1.000 h
Interval 1.0 to 2.0
|
1.000 h
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: up to 30 days after last dosePopulation: Subjects who received at least one dose of study drug were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Treatment-emergent Adverse Events
|
4 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 17Population: Subjects having both baseline and Day 17 blood pressure measurements were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure
|
3.8 mmHg
Standard Deviation 10.40
|
-2.3 mmHg
Standard Deviation 8.33
|
2.3 mmHg
Standard Deviation 4.93
|
10.7 mmHg
Standard Deviation 11.15
|
5.5 mmHg
Standard Deviation 5.75
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure
|
2.9 mmHg
Standard Deviation 6.36
|
-0.3 mmHg
Standard Deviation 8.48
|
0.5 mmHg
Standard Deviation 6.75
|
3.3 mmHg
Standard Deviation 7.55
|
4.0 mmHg
Standard Deviation 4.34
|
PRIMARY outcome
Timeframe: Baseline and Day 17Population: Subjects having both baseline and Day 17 SpO2 measurements were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Change From Baseline in SpO2
|
0.6 % (percentage of oxygen saturation)
Standard Deviation 0.92
|
0.3 % (percentage of oxygen saturation)
Standard Deviation 0.82
|
1.5 % (percentage of oxygen saturation)
Standard Deviation 0.55
|
0.5 % (percentage of oxygen saturation)
Standard Deviation 1.05
|
-0.2 % (percentage of oxygen saturation)
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Baseline and Day 17Population: Subjects having both baseline and Day 17 QTcF measurements were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Change From Baseline in ECG QTcF Interval
|
-4.6 msec
Standard Deviation 14.28
|
-12.5 msec
Standard Deviation 8.46
|
-4.3 msec
Standard Deviation 9.00
|
-0.3 msec
Standard Deviation 23.72
|
-8.7 msec
Standard Deviation 9.31
|
PRIMARY outcome
Timeframe: Baseline and Day 17Population: Subjects having both baseline and Day 17 AST measurements were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase
|
-0.3 U/L
Standard Deviation 2.12
|
-0.8 U/L
Standard Deviation 6.08
|
-1.5 U/L
Standard Deviation 3.94
|
-3.7 U/L
Standard Deviation 4.27
|
2.0 U/L
Standard Deviation 7.48
|
PRIMARY outcome
Timeframe: Baseline and Day 17Population: Subjects having both baseline and Day 17 ALT measurements were included in the analysis population.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Matching placebo once daily for 14 days
|
0.75 mg ITI-333
n=6 Participants
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 Participants
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 Participants
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 Participants
6 mg ITI-333 oral solution once daily for 14 days
|
|---|---|---|---|---|---|
|
Change From Baseline in Alanine Aminotransferase
|
2.8 U/L
Standard Deviation 3.41
|
0.0 U/L
Standard Deviation 16.61
|
2.8 U/L
Standard Deviation 14.65
|
1.5 U/L
Standard Deviation 15.60
|
4.3 U/L
Standard Deviation 19.37
|
Adverse Events
0.75 mg ITI-333
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.5 mg ITI-333
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 mg ITI-333
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
6 mg ITI-333
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.75 mg ITI-333
n=6 participants at risk
0.75 mg ITI-333 oral solution once daily for 14 days
|
1.5 mg ITI-333
n=6 participants at risk
1.5 mg ITI-333 oral solution once daily for 14 days
|
3 mg ITI-333
n=6 participants at risk
3 mg ITI-333 oral solution once daily for 14 days
|
6 mg ITI-333
n=6 participants at risk
6 mg ITI-333 oral solution once daily for 14 days
|
Pooled Placebo
n=8 participants at risk
Matching placebo once daily for 14 days
|
|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
12.5%
1/8 • Up to 30 days after the last dose
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
12.5%
1/8 • Up to 30 days after the last dose
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
50.0%
3/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
25.0%
2/8 • Up to 30 days after the last dose
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
12.5%
1/8 • Up to 30 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
12.5%
1/8 • Up to 30 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
16.7%
1/6 • Up to 30 days after the last dose
|
0.00%
0/8 • Up to 30 days after the last dose
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
0.00%
0/6 • Up to 30 days after the last dose
|
12.5%
1/8 • Up to 30 days after the last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place