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:

Healthy adults:

• Men aged 18 to 45 weighing at least 50kg, or women aged 18 to 60 weighing at least 45kg, with a Body Mass Index (BMI — a measure of body weight relative to height) between 19.0 and 26.0
• People whose general health checks — including physical examination, vital signs, blood tests, and heart tracing (ECG) — come back normal or with no medically important findings
• Male participants who are willing to use effective contraception during the study and for 6 months after it ends; female participants who are not able to become pregnant
• People who are able to understand and follow the study instructions, and who have chosen freely to take part and sign a consent form

Adults with schizophrenia:

• Men or women aged 18 to 65 with a BMI between 18.5 and 30; men weighing at least 50kg, women weighing at least 45kg
• Male participants who are willing to use effective contraception during the study and for 6 months after it ends; female participants who are not able to become pregnant
• People who have had a confirmed primary diagnosis of schizophrenia for at least 1 year, based on a full psychiatric assessment using recognised diagnostic tools (DSM-5 and MINI)
• People who are currently experiencing a worsening or return of psychotic symptoms
• People whose symptom scores at the screening stage reach specific thresholds on two standard rating scales used by clinicians (PANSS total score of at least 70 and CGI-S score of 4 or more)
• People who have previously been treated with antipsychotic medications
• People (and their guardians where relevant) who fully understand the trial requirements, choose freely to take part, sign a consent form, and are willing to complete the full trial

Who may not be able to join:

Healthy adults:

• People with a current or past history of significant illness or dysfunction affecting any major body system — including the brain and nervous system, heart, lungs, digestive system, kidneys, hormones, blood, or eyes — or a history of cancer, as assessed by the trial doctor
• People with a current or previous mental health condition or brain disorder, any risk of suicide as judged by the trial doctor, or a history of self-harm
• People with past surgery or conditions that could significantly affect how the body processes medication — such as stomach removal, bowel surgery, urinary blockage, stomach ulcers, or a history of gastrointestinal bleeding
• People with a known allergy to any ingredient in the study drug or similar medications, or a history of significant allergic conditions
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV
• People who have had surgery within 3 months before screening, have not fully recovered from surgery, or have planned surgery during the trial period
• People who have donated or lost 400mL or more of blood in the 3 months before screening, or 200mL or more in the month before screening, or who have received blood products in the 3 months before screening
• People who have taken any prescription medicines, over-the-counter medicines, or herbal or vitamin supplements in the 2 weeks before screening
• People who have used certain medications known to affect how the liver breaks down drugs (including specific antibiotics, antifungals, anti-seizure medicines, and steroids) within 4 weeks before screening, or within 5 half-lives of those drugs — whichever is longer
• People who have taken part in another clinical trial or received a trial drug within 3 months before screening, or who are currently in another trial
• People who have smoked more than 5 cigarettes per day or drunk more than 5 cups of coffee or tea per day in the 3 months before screening, or who are unable to stop during the study; people who test positive on a smoking test
• People who have had an alcohol use problem in the past year, drink more than 14 standard units of alcohol per week on average, or test positive on a breath alcohol test (one standard unit is approximately 360mL of regular beer, 45mL of spirits, or 150mL of wine)
• People with a history of illegal drug use in the past year, or who test positive on a urine drug screen
• People with a family history of sudden cardiac death in a relative under age 40
• People whose resting heart rate, blood pressure readings, or blood pressure response to standing fall outside the acceptable ranges set by the trial (confirm with trial site)
• People with a clinically significant abnormality on a 12-lead ECG (heart tracing), including a specific heart rhythm measurement — QTcF — above 450ms in men or 470ms in women
• People with abnormal results on certain blood tests (including liver enzymes, kidney markers, prolactin hormone levels, or white blood cell counts) that fall outside normal ranges
• People with specific dietary requirements that prevent them from following a standard study diet, or who have difficulty swallowing
• People who are unwilling to avoid smoking, alcohol, caffeine-containing drinks, and strenuous exercise during the trial
• People who are directly involved in running this clinical trial
• People the trial doctor considers unsuitable for any other reason

Adults with schizophrenia:

• People who also meet the diagnostic criteria for another mental health condition under DSM-5
• People whose schizophrenia has not responded to at least 2 different antipsychotic medications given at adequate doses over the past 5 years (sometimes called treatment-resistant schizophrenia)
• People who answer "yes" to certain questions about thoughts of suicide on a standard scale (C-SSRS questions 4 or 5), who have shown clear signs of suicidal thinking or violent behaviour in the past 12 months, or who the trial doctor considers to be at risk
• People with significant ongoing illness or poorly controlled medical conditions affecting any major body system — including neurological, heart, kidney, digestive, lung, muscle, hormonal, blood, immune, skin, or cancer-related conditions — as assessed by the trial doctor
• People with a history of surgery or conditions that could significantly affect how the body processes medication — such as stomach or bowel surgery, urinary blockage, stomach ulcers, or gastrointestinal bleeding
• People with a history of epilepsy, except for childhood febrile (fever-related) seizures
• People with a history of a serious drug reaction known as malignant syndrome (a rare but severe reaction to certain medications)
• People with a history of severe allergic reactions
• People who have received electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (a type of brain stimulation treatment) within 3 months before screening
• People who are currently taking or have recently taken (within a specific washout period before the baseline visit) oral antipsychotic medications, antidepressants, or mood-stabilising medications
• People who have recently used certain medications known to strongly or moderately affect how the liver breaks down drugs, within a specified period before joining (confirm with trial site)
• People with physical examination findings unrelated to schizophrenia that the trial doctor considers may affect the trial
• People whose resting heart rate, blood pressure, or blood pressure response to standing fall outside the acceptable ranges set by the trial (confirm with trial site)
• People with a clinically significant abnormality on a 12-lead ECG, including a QTcF measurement above 450ms in men or 470ms in women
• People with certain abnormal blood test results at screening, including liver enzyme levels (ALT or AST) at 1.5 times or more above normal, kidney markers above normal, or prolactin hormone levels at 5 times or more above normal
• People with a history of illegal drug use in the past year, or who test positive on a urine drug screen
• People who have had an alcohol use problem in the past year, drink more than 14 standard units of alcohol per week on average, or test positive on a breath alcohol test
• People who are unwilling to avoid smoking, alcohol, caffeine-containing drinks, and strenuous exercise during the trial
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV
• People who have donated or lost 400mL or more of blood in the 3 months before screening, or 200mL or more in the month before screening
• People who have taken part in another clinical trial or received a trial drug within 3 months before screening, or who are currently in another trial
• People the trial doctor considers unsuitable for any other reason

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