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ITI-333 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Intra-Cellular Therapies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively

Awards & highlights

Study Summary

This trial will test a new drug on 8 healthy people to see if it's safe & effective. 6 will get the drug, 2 will get a placebo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in ECG QT interval

Change from baseline in SpO2

Change from baseline in alanine aminotransferase

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: 6 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions

Group II: Cohort 3: 3 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions

Group III: Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions

Group IV: Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ITI-333

2020

Completed Phase 1

~50

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor

29 Previous Clinical Trials

7,115 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,467 Previous Clinical Trials

2,619,091 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prerequisites for enrolling in this research trial?

"The eligibility criteria for this trial requires that candidates must be between 18 and 45 years old and in good physical health. Currently, 32 participants are being recruited to take part."

Answered by AI

Is enrollment for this clinical experiment ongoing?

"According to clinicaltrials.gov, this medical research is currently accepting participants. The trial was initially advertised on January 18th 2023 and the information was last revised on March 2nd 2023."

Answered by AI

How many individuals have the capacity to register for this research endeavor?

"Affirmative. The clinicaltrial.gov website shows that this study, which was initially posted on January 18th 2023, is actively seeking participants. Specifically, 32 patients need to be found from two sites."

Answered by AI

Is the age requirement for this clinical experiment greater than twenty years?

"The age range for inclusion in this trial is 18 to 45, as outlined by the eligibility criteria."

Answered by AI

Has this intervention been authorized by the Food and Drug Administration?

"The safety of this intervention has been estimated at a 1, as it is in the initial stage of clinical trials and data regarding its efficacy and security are still scarce."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05732194.