EUCTR2020-003796-17-GB进行中（未招募）1 期
An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part A – healthy subjects
- •A subject will be considered eligible for enrollment if all of the following criteria are met:
- •1. Males and females aged 40-75 years (inclusive) at the time of informed consent
- •2. Body weight = 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive at Screening
- •3. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.
- •Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the End of Study Visit
- •4. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from 30 days prior to Day 1 through 30 days after the last study medication administration:
- •a. use a reliable method of birth control, or
- •b. monogamous relationship with a male partner of confirmed sterility, or
- •c. practice complete abstinence
- •5. Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal or have undergone surgical sterilization
- •6. Subject is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory assessments conducted at Screening
- •7. Able to speak, read and understand English
- •8. Able to understand and sign the written informed consent form (ICF)
- •9. Willing to follow the protocol requirements and comply with protocol restrictions
- •Parts B and C – subjects with MCI or PD
- •MCI or PD subjects must meet the following criteria:
- •10. Males and females aged 40-75 years (inclusive) at the time of informed consent
- •11. Montreal Cognitive Assessment (MoCA) score =18 and =26
- •12. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the End of Study Visit.
- •13. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration:
- •a. use a reliable method of birth control, or
- •b. monogamous relationship with a male partner of confirmed sterility, or
- •c. practice complete abstinence
- •14. Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal or have undergone surgical sterilization
- •15. Stable medical conditions for 3 months prior to Screening visit (e.g., diabetes, hypertension, dyslipidemia)
- •16. If already being administered, vitamin E (up to 400 IU daily), estrogens, aspirin (75-300 mg daily), blood pressure medications (except for adrenergic agents), diabetic medications, and cholesterol-lowering agents for 3 months prior to screening is allowed.
- •17. In generally good health, in
排除标准
- •A subject with any of the following criteria will not be eligible for participation.
- •1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
- •2. History of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- •3. A calculated creatinine clearance of =70 mL/min according to the Cockcroft-Gault
- •4. Uncontrolled hypertension (systolic blood pressure = 140 or diastolic blood pressure = 90 mmHg) at Screening or Day -1.
- •5. History of drug or alcohol abuse =12 months prior to Screening.
- •6. A positive test for drugs of abuse or alcohol during Screening.
- •7. Unwilling or unable to abstain from alcohol from 2 days prior to Day 1 until end-of-study assessments.
- •8. Use of over-the-counter medication (other than paracetamol up to 2 g per day), or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the CuraSen Medical Monitor.
- •9. Subjects on monoamine oxidase type B inhibitors, dopamine agonists or catechol-O-methyltransferase inhibitors are not allowed.
- •10. Current or prior treatment with any beta agonists or beta blockers within the last month prior to Day 1.
- •11. Opioid use within 1 month prior to screening or during the study.
- •12. Use of St. John’s Wort or Ginkgo Biloba within 1 month prior to study enrollment.
- •13. Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening). Subjects with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
- •14. Positive screening test for human immunodeficiency virus (HIV).
- •15. Positive screening test for or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or documented history of prior infection.
- •16. Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is above 1.5 X above the upper limit of normal, or any out-of-range value for serum sodium or potassium. Screening tests may be repeated once at the discretion of the Investigator.
- •17. Clinically significant laboratory or ECG abnormality that could be a safety issue in the study, including QT using Fredericia’s correction of QT interval (QTcF) >450 msec (males) or >470 msec (females).
- •18. History of angina, heart failure, coronary insufficiency, cardiac arrythmias, hyperthyroidism, hypothyroidism, or convulsion disorders.
- •19. Prior treatment with any investigational drug =90 days prior to dosing (Day 1), or =5 half-lives of the drug (whichever is longer), or current enrolment in any other study treatment or disease study.
- •20. Donation or loss of =500 mL of blood or plasma within 30 days prior to dosing.
- •21. Inability to undergo a clinical MRI of the brain due to claustrophobia, or other contraindications to undergoing an MRI of the brain including, but not limited to, pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clip
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