Phase 1 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For healthy volunteers:

• Men and women between 18 and 65 years old at the time of signing consent, with at least one quarter of each group being of the same sex
• People with a body mass index (BMI) between 19.0 and 26.0, and who weigh at least 45 kg (women) or 50 kg (men)
• People who are not planning a pregnancy, sperm donation, or egg donation from the time of signing consent until one year after the last dose, and who agree to use effective contraception during that time
• People who have read and understood the trial information, including possible side effects, and have signed a consent form
• People who can communicate clearly with the research team and are willing to follow the study requirements

For people with schizophrenia:

• Men and women between 18 and 65 years old at the time of signing consent, with at least one quarter of each group being of the same sex
• People who have been diagnosed with schizophrenia according to an international diagnostic standard (ICD-10), whose symptom score on a standard rating scale (PANSS) is 70 or below, and whose condition has been considered stable by the doctor for at least four weeks before the screening visit
• People with a BMI of at least 18.5 and below 35.0, and who weigh at least 45 kg (women) or 50 kg (men)
• People who are able to complete a required tolerance test as specified in the study plan
• People who are not planning a pregnancy, sperm donation, or egg donation from the time of signing consent until one year after the last dose, and who agree to use effective contraception during that time
• People whose legal guardian (if applicable) has also signed the consent form
• People (and their guardians, where applicable) who agree to follow the study plan and cooperate with the research team

Who may not be able to join:

For healthy volunteers:

• People with a significant history of heart, hormonal, kidney, nervous system, blood, immune system, or metabolism conditions that the doctor considers still clinically relevant
• People whose physical examination, vital signs, heart trace (ECG), or blood and urine test results are considered abnormally significant by the doctor
• People who have taken any brexpiprazole tablets within 28 days before the oral tolerance test
• People who have previously enrolled in a clinical trial of brexpiprazole long-acting injection and received the study drug
• People who have participated in another drug or medical device clinical trial and received the study treatment within 28 days before dosing (unless it was an observational study only)
• People who have taken any medications that interact with brexpiprazole — including certain liver enzyme affecting drugs (CYP3A4 or CYP2D6 inducers or inhibitors) — within 30 days before dosing (except skin-applied products with only local effects)
• People who have taken any prescription, over-the-counter, or herbal medicines within 14 days before dosing (except skin-applied products with only local effects)
• People who have eaten foods or drinks high in xanthine (such as sardines or animal liver), grapefruit or similar citrus fruits, or caffeine (such as coffee, strong tea, or cola) within 48 hours before dosing, or any other foods that could affect how the body processes the drug
• People who regularly drink more than 8 cups (250 mL each) per day of tea, coffee, or similar caffeinated or grapefruit-containing drinks
• People with a history of heavy alcohol use (more than 28 standard drinks per week for men, or more than 21 for women), or frequent drinking in the 6 months before screening, or who are unwilling to stop drinking from screening until the last blood sample is taken
• People who have smoked more than 3 cigarettes per day in the 3 months before dosing, or who are unwilling to stop using tobacco products from screening until the last blood sample is taken
• People with a history of drug dependence or drug abuse
• People who test positive for drugs of abuse in a urine test
• People who test positive for alcohol in a breath test
• People who have donated or received blood or blood products (more than 200 mL) within 1 month before dosing
• People who have had surgery in the month before dosing, or who plan to have surgery between screening and the last blood sample
• People who are allergic to any ingredient in the study drug, or who have a history of allergies to two or more drugs or foods
• People with a clinically significant history of fainting at the sight of needles or blood, as judged by the doctor
• Women who are pregnant or breastfeeding
• People who have had unprotected sex within 2 weeks before dosing
• People the doctor considers unsuitable for the trial for any other reason

For people with schizophrenia:

• People who have another psychiatric diagnosis in addition to schizophrenia (except conditions considered part of the schizophrenia presentation) according to ICD-10
• People who have participated in another drug or medical device clinical trial and received the study treatment within 28 days before dosing (unless it was an observational study only)
• People who have taken brexpiprazole tablets for tolerance testing within 28 days before the oral tolerance test
• People who have previously enrolled in a clinical trial of brexpiprazole long-acting injection and received the study drug
• People who are currently taking more than one other antipsychotic medication in addition to the brexpiprazole tablets given for tolerance testing (one additional antipsychotic may be allowed if it has been taken at a stable dose for at least 14 days before dosing)
• People who have received another long-acting injectable antipsychotic and have not yet reached the point in the treatment cycle where the next injection would be due
• People with significant heart or brain blood vessel conditions, including: heart failure; serious irregular heartbeat requiring treatment; heart disease requiring treatment; congenital heart conditions; serious structural heart disease; a stroke or mini-stroke within the past year; certain abnormal heart rhythm measurements on ECG; a significant drop in blood pressure when standing up; a resting heart rate below 50 or above 100 beats per minute; or uncontrolled high blood pressure
• People with poorly controlled diabetes, as indicated by a blood sugar marker (HbA1c) of 7.0% or above
• People whose blood test results before dosing show abnormal levels of white blood cells, neutrophils, platelets, red blood cells, or haemoglobin below the specified thresholds; or whose liver function markers (bilirubin, ALT, or AST) are more than twice the upper limit of normal; or whose kidney function marker (creatinine) is more than 1.5 times the upper limit of normal; or whose muscle enzyme (creatine kinase) is more than 3 times the upper limit of normal
• People with a history of heavy alcohol use or who are unwilling to stop drinking from screening until the last blood sample is taken (same criteria as for healthy volunteers above)
• People who regularly drink more than 8 cups (250 mL each) per day of tea, coffee, or similar caffeinated or grapefruit-containing drinks
• People who have smoked more than 3 cigarettes per day in the 3 months before dosing, or who are unwilling to stop using tobacco products from screening until the last blood sample is taken
• People who test positive for alcohol in a breath test
• People with a history of drug dependence or drug abuse
• People who test positive for drugs of abuse in a urine test
• People who have donated or received blood or blood products (more than 200 mL) within 1 month before dosing
• People who have had surgery in the month before dosing, or who plan to have surgery between screening and the last blood sample
• People with Parkinson's disease, a history of a serious drug reaction called malignant syndrome, or dementia-related psychosis
• People with a history of, or current, involuntary abnormal movements (tardive dyskinesia) or severe restlessness (akathisia) above specified severity thresholds on standard rating scales
• People with epilepsy or a condition involving seizures (except childhood fever-related convulsions)
• People assessed as having a significant risk of suicide, based on responses to a standard suicide assessment scale (C-SSRS) or in the opinion of the doctor
• People with a clinically significant history of fainting at the sight of needles or blood, as judged by the doctor
• People who are allergic to any ingredient in the study drug, or who have a history of allergies to two or more drugs or foods
• People who have received electroconvulsive therapy (ECT) within 14 days before screening
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• Women who are pregnant or breastfeeding
• People who have had unprotected sex within 2 weeks before dosing
• People who have taken traditional Chinese medicine preparations within 14 days before dosing, or certain liver enzyme-affecting drugs within 7 days (or 5 drug half-lives, whichever is longer), or who have eaten certain foods such as grapefruit, high-caffeine, or xanthine-rich foods within 48 hours before dosing (except skin-applied products with only local effects)
• People the doctor considers unsuitable for the trial for any other reason

Important: Always verify eligibility with the trial site directly before applying.