Loading clinical trials...

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. | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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.

A Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Brexpiprazole Long-acting Injection in Healthy Subjects/Patients With Schizophrenia.

NCT06674694•Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed Description

The 20mg group and 40mg group of the study will evaluate the safety and tolerability, PK of single ascending doses of of brexpiprazole long-acting injection in 24 healthy subjects,other groups of the study will evaluate the safety and tolerability, PK of single ascending doses of of brexpiprazole long-acting injection in 32 patients with schizophrenia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Volunteers:
•1. 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);
•2. 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;
•3. 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;
•4. Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
•5. Subjects can communicate well with the investigator, and understand and comply with the requirements of this study.
•Patients with schizophrenia:
•1. 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);
•2. 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;
•3. Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35.0 kg/m2, and female weight ≥ 45 kg, male weight ≥ 50 kg;
+4 more criteria

Exclusion Criteria

•Healthy Volunteers:
•1. 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;
•2. 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;;
•3. Those who have taken any brexpiprazole preparation within 28 days prior to oral tolerance test drugs (brexpiprazole tablets);
•4. Those who have been enrolled in clinical trials of brepiprazole long-acting injection and have received the test drug administration;
•5. 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;
•6. 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);
•7. 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);
•8. 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;
•9. 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;
+42 more criteria

Locations (1)

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 10, 2024

Primary Completion Date

June 30, 2026

Completion Date

October 30, 2026

Last Updated

November 17, 2025

Enrollment

ESTIMATED participants

Conditions

Schizophrenia Disorders

Interventions

Brexpiprazole long-acting injection

DRUG

Contacts

Wei Qi

CONTACT

028-82339360 qiw@kelun.com

Brain Stimulation to the Hippocampus in Schizophrenia

NCT07010614

Schizophrenia DisordersMental Disorder+1 more

View study

RECRUITINGNA

White Matter Plasticity in Schizophrenia

NCT06641297

Schizophrenia Disorders

View study

RECRUITINGPHASE2

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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.

Inclusion Criteria

Exclusion Criteria

Brain Stimulation to the Hippocampus in Schizophrenia

White Matter Plasticity in Schizophrenia

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis

Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation

40 Hz Visual Stimulation as an Intervention in Schizophrenia