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 participants:

• You are willing to sign a consent form to take part in the study.
• You are a man or woman between 18 and 45 years old.
• You weigh at least 50 kg (if male) or at least 45 kg (if female), and your BMI (a measure of body weight relative to height) is between 18.5 and 26.0.

For participants with schizophrenia:

• You (and/or your legal guardian) are willing to sign a consent form to take part in the study.
• You are a man or woman between 18 and 60 years old.
• You weigh at least 50 kg (if male) or at least 45 kg (if female), and your BMI is between 18.5 and 32.0.
• You have been formally diagnosed with schizophrenia, your symptoms are considered mild to moderate based on standard rating scales, and your condition has been stable for at least one month before the study begins (confirm with trial site).

Who may not be able to join:

For healthy participants:

• You have any significant ongoing health condition or chronic illness.
• You have taken any over-the-counter medicines in the last 7 days, or any prescription medicines in the last 28 days before the study drug is given.
• You have a history of eye conditions such as cornea problems, retinal disease, high eye pressure, or a specific type of glaucoma, or you had an abnormal eye exam during screening.
• You have a history of feeling faint when standing up, or of passing out.
• You have a condition that could significantly affect how your body processes medicines (confirm with trial site).
• You had surgery within the 3 months before the study, have not fully recovered from a past surgery, or are planning surgery during the study.
• You have significantly abnormal results from vital sign checks (such as blood pressure or heart rate), blood tests, or heart tracings (ECGs).
• You have a history of allergies, or are allergic to any ingredient in the study medication.
• You test positive for hepatitis B, hepatitis C, HIV, or syphilis.

For participants with schizophrenia:

• You have been diagnosed with another mental health condition (other than schizophrenia) in the 6 months before screening.
• Your schizophrenia has not responded to treatments, you have a history of a serious medication reaction called neuroleptic malignant syndrome, or your antipsychotic medication may need to be changed during the study.
• You have attempted suicide or had serious thoughts of suicide in the past 6 months, as measured by a standard assessment tool (confirm with trial site).
• You have taken a type of medication called MAOIs in the last 28 days, or any dietary supplements or herbal products in the last 7 days before the study drug is given.
• Your blood sugar control level (HbA1c) is 7% or higher at screening.
• You have a heart condition such as a genetic long QT heart rhythm disorder, significant heart failure, unstable chest pain, a heart attack within the last 6 months, a serious irregular heartbeat, a resting heart rate below 50 beats per minute, or abnormal heart rhythm measurements on an ECG (confirm with trial site).
• You have a history of eye conditions such as cornea problems, retinal disease, high eye pressure, or a specific type of glaucoma, or you had an abnormal eye exam during screening.
• You have a history of feeling faint when standing up, or of passing out.

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