The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.

Recruiting now · Phase 1

Conditions studied: Schizophrenia Disorders

In brief

Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.

Key facts

Study ID

NCT06674694

Run by

Sichuan Kelun Pharmaceutical Co.,Ltd.

People needed

56

Starts

2024-04-10

Expected to finish

2026-10-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Volunteers:
• Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
• Body mass index (BMI) in the range of 19.0-26.0 (including the critical value), and female weight ≥ 45 kg, male weight ≥ 50 kg;
• Subjects of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed consent form to within 1 year after the last dose of the investigational drug, and voluntarily take effective contraceptive measures;
• Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Subjects can communicate well with the investigator, and understand and comply with the requirements of this study.
• Patients with schizophrenia:
• Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
• Patients diagnosed with schizophrenia according to ICD-10, and the positive and negative symptom scale (PANSS) score ≤ 70 points, and the investigator judged stable disease within 4 weeks before screening;
• Body mass index (BMI) ≥ 18.5 kg/m2 and < 35.0 kg/m2, and female weight ≥ 45 kg, male weight ≥ 50 kg;
• Subjects need to complete the tolerance test according to the protocol requirements;
• Subjects of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed consent form to within 1 year after the last dose of the investigational drug, and voluntarily take effective contraceptive measures;
• Subjects and their guardians signed informed consent;
• Subjects and their guardians agree to comply with the protocol and cooperate with the investigator to complete the trial.

You may not qualify if…

• Healthy Volunteers:
• History of cardiovascular system (such as history of ischemic heart disease), endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, and the researchers believe that there is still clinical significance;
• Physical examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests (including hematology, urinalysis, serum biochemistry, thyroid panel, coagulation panel, serum prolactin, virological examination, lipid panel, serum pregnancy test (only women of childbearing age) and glycosylated hemoglobin, etc.), chest X-ray or CT and B-ultrasound with Injection site results in injection site are abnormal and clinically significant;;
• Those who have taken any brexpiprazole preparation within 28 days prior to oral tolerance test drugs (brexpiprazole tablets);
• Those who have been enrolled in clinical trials of brepiprazole long-acting injection and have received the test drug administration;
• Participate in any drug or medical device clinical trial and receive the treatment of the investigational drug or medical device within 28 days before dosing (other than the drug/equipment used in this study), except for subjects participating in the research or observational study;
• Those who have used any drugs that interact with brepiprazole within 30 days before administration [including CYP3A4 inducers and inhibitors, CYP2D6 inducers and inhibitors] (except topical preparations with local effects);
• Those who have used any drugs within 14 days before administration [including prescription drugs, over-the-counter drugs, traditional Chinese medicine, etc.] (except topical preparations with local effects);
• Consumption of foods or beverages rich in xanthine (such as sardines, animal liver, etc.), grapefruit (such as grapefruit, western grapefruit, lime, carambola, etc.), caffeine (such as coffee, strong tea, cola, milk tea, etc.) within 48 hours before dosing, or other special diet that can affect drug absorption, distribution, metabolism and excretion;
• Those who drink excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea or coffee or beverages rich in xanthine/caffeine/grapefruit (such as milk tea, cola, fruit juice, etc.) before administration;
• Previous alcohol abuse (i.e., men drink more than 28 standard units per week, women drink more than 21 standard units per week (1 standard unit contains 14 g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or frequent alcohol consumption within the first 6 months before screening (more than 14 standard units per week) and determined by the investigator to affect the test, or unwilling to stop drinking or any alcohol-containing products from the date of screening to the last PK blood collection period;
• Those who smoke more than 3 cigarettes per day within 3 months before dosing, or are unwilling to stop using any tobacco products from the date of screening to the last PK blood collection in the trial;
• Those with a history of drug dependence or a history of drug abuse;
• Positive urine drug abuse screening;
• Alcohol breath test positive;
• Those who donate blood or transfuse blood products or use blood products within 1 month before administration (> 200 mL);
• Those who have undergone surgery within 1 month before administration, or who plan to undergo surgery from the date of screening to the last PK blood collection period of the trial;
• Those who are allergic or allergic to any component of this product and excipients (allergic to two or more drugs or food);
• History of needle sickness or blood sickness with clinical significance judged by the investigator to;
• Pregnant or lactating women;
• Those who have unprotected sex within 2 weeks prior to administration;
• The investigator judged that it was not suitable to participate in this trial.
• Patients with schizophrenia:
• Patients with other psychiatric diseases other than schizophrenia diagnosed according to ICD-10 (except the diagnosis of concomitant symptoms of schizophrenia);
• Participate in any drug or medical device clinical trial and receive the treatment of the investigational drug or medical device within 28 days before dosing (other than the drug/equipment used in this study), except for subjects participating in the research or observational study;

Where it is running

• Beijing Anding Hospital Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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