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

Starting soon · Phase 1/Phase 2

Conditions studied: Schizophrenia Disorder

In brief

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.

Key facts

Study ID: NCT07626034
Run by: Shanghai Zhongze Therapeutics Co., Ltd.
People needed: 9
Starts: 2026-08-01
Expected to finish: 2027-12-01
Last updated by the study team: 2026-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy Volunteers
Participant is aged 18-55 years, inclusive.
BMI between 19.0 and 32.0 kg/m2, inclusive.
Participant is medically healthy as determined by clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the Screening visit and before administration of the initial dose of study drug.
Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Participant is capable of providing informed consent.
A signed informed consent form must be provided before any study assessments are performed.
Participant must be fluent (oral and written) in English to consent.
Patients with schizophrenia
Participant is aged 18-55 years, inclusive.
BMI between 19.0 and 35.0 kg/m2, inclusive.
Currently meet a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis and differential will be confirmed by using the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies version 7.0.2 at Screening Visit.
The participant is currently stable: the total Positive and Negative Syndrome Scale (PANSS) score ≤ 60, including P7 (hostile) and G8 (not cooperative) scored ≤ 4.
Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Participant is capable of providing informed consent.
A signed informed consent form must be provided before any study assessments are performed.
Participant must be fluent (oral and written) in English to consent.

You may not qualify if…

Healthy Volunteers
Women of childbearing potential (WOCBP), or fertile men whose sexual partners are WOCBP, who are unwilling or unable to use at least 1 highly effective method of contraception during the study and for 90 days following the last dose of trial medication. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
Females who are pregnant, lactating, or less than 90 days postpartum prior to the Screening Visit.
History or presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease, considered by the investigator.
Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" to any of the 5 items (C-SSRS - ideation) within the 3 months before Screening or between the Screening and Baseline Visits, or answers "Yes" to any of the 5 items (C-SSRS behavior) within the 12 months before Screening or between the Screening and Baseline Visits, or has a history of nonsuicidal, self-injurious behavior in the past 12 months.
History of current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg) and/or anti- hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies or treponema pallidum antibody.
Participants who had any major surgery, any blood transfusion, donation of blood or plasma within 30 days prior to Screening Visit.
Participants with a history of allergy to more than one class of medications or known to be allergic to any components of the study drug or the radioligand.
Physical and Laboratory Results
Clinically significant abnormal findings on the physical examination, vital signs, 12-lead ECG, or clinical laboratory results.
The following laboratory tests are exclusionary:
Neutrophils, absolute <= 1000/mm3
Aspartate Aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
Alanine Aminotransferase (ALT) > 1.5 times upper limit of normal
Total Bilirubin (TBil) > 1.5 times upper limit of normal
Creatinine >1.2 times upper limit of normal
Clinically significant abnormal findings on 12-ECG and/or evidence of any of the following cardiac conduction abnormalities:
Heart rate < 50 bpm or > 110 bpm (based on the ECG reading)
QTcF interval > 450 msec for males and > 470 msec for females
Evidence of second- or third-degree atrioventricular block (AVB)
Participants who test positive for drugs of abuse at Screening Visit or Baseline Visit are excluded.
Use of any prescription medications or over-the-counter (OTC) medications, including health supplements, vitamins or herbal remedies within 7 days or within 5 half-lives of the medication, whichever is longer, prior to Baseline Visit.
Participants who would be likely to require prohibited concomitant therapy during the study.
Participants who suffer from claustrophobia.
Participants with magnetic resonance imaging (MRI)-incompatible implants and other contraindications for MRI, such as pacemakers, artificial joints, nonremovable body piercings, tattoos larger than 1 cm in diameter, metal fragments, etc.

Full record on ClinicalTrials.gov

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