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A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by SIPI6398

NCT07626034 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-06-04

No results posted yet for this study

Summary

This is an open label study in 2 cohorts of healthy volunteers and 1 cohort of patients with Schizophrenia, designed to evaluate the Dopamine D2 and D3 Receptor Occupancy by SIPI6398 at various doses and timepoints.

Conditions

  • Schizophrenia Disorder

Interventions

DRUG

SIPI6398 Tablets

SIPI6398 Tablets will be administered orally once daily for 7 consecutive days to healthy volunteers or for 8 consecutive days to patients with schizophrenia.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Shanghai Zhongze Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626034 on ClinicalTrials.gov