NCT07626034尚未招募1 期
An Open-label Positron Emission Tomography (PET) Study to Evaluate Brain Dopamine D2 and D3 Receptor Occupancy by SIPI6398 in Healthy Volunteers and Patients With Schizophrenia
Shanghai Zhongze Therapeutics Co., Ltd.0 个研究点目标入组 9 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≤
- •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.
排除标准
- •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.
- •Participants who have received a diagnostic or therapeutic radiopharmaceutical within 30 days prior to Screening Visit.
- •Participation in other research trials involving ionizing radiation within 1 year of the PET scans that would cause the participant to exceed the yearly dose limits for participants.
- •Severe motor problems that prevent the participant from lying still for PET and MRI.
- •Within 6 months prior to Screening Visit:
- •> 21 cigarettes per day;
- •consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent in caffeinated beverages);
- •for alcohol, an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
- •Unwilling or unable to comply with lifestyle considerations.
- •Participants who received any investigational agent or device in a clinical trial within 90 days prior to Screening Visit.
- •Participant does not tolerate venipuncture or has poor venous access that would cause difficulty for administration of the radioisotope and for collecting blood samples.
- •Participant is, in the opinion of the investigator, unsuitable in any other way to participate in this study.
- •Patients with schizophrenia
- •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.
- •Participant has any of the following psychiatric conditions per DSM-5 criteria, as assessed by the M.I.N.I version 7.0.
- •Conditions not assessable by the M.I.N.I should be assessed by clinical judgment.
- •Substance use disorder within the past 12 months (other than nicotine, alcohol or caffeine).
- •Bipolar I or Ⅱ disorder; obsessive-compulsive disorder; post-traumatic stress disorder; neurocognitive disorders; or other psychotic disorders.
- •Intellectual disabilities.
- •Any other psychiatric condition that could interfere with participation in the study.
- •Mild depressive or anxiety symptoms are permitted if, in the opinion of the investigator, they are considered secondary to the diagnosis of schizophrenia and do not require specific pharmacological intervention.
- •Participants who experience clinical deterioration during the drug-free interval prior to Baseline Visit, such that they require prohibited rescue therapy.
- •Participant who is judged to be resistant to antipsychotic treatment by the investigator, based on failure to respond to 2 or more marketed antipsychotic agents, given at adequate dose for at least 6 weeks.
- •Participant have a history of failure to clozapine, or who are responsive only to clozapine treatment.
- •Risk of violent or destructive behavior.
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