Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/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);
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;
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;
Parallel
Brexpiprazole long-acting injection
DrugA single injection was administered.
6
Treatment groupsSee each treatment group below.
Number of reported Adverse Events (AE)
Safety and tolerability was assessed by the number of participants with adverse events (AE).
Clinical Laboratory Tests
Hematology, Serum chemistry, Lipid Panel, Glycated Hemoglobin, Urinalysis, Coagulation Panel will be performed.
Change in physical exam results
Investigator will perform complete physical exam and document any clinically significant conditions. Body height and weight will also be measured for BMI calculation and weight will be measured as part of all subsequent physical exams.
Vital signs
Vital signs include respiration, temperature, pulse, and blood pressure.
Maximum peak plasma concentration (Cmax) [Pharmacokinetics]
Samples will also be collected until 90 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Time of Cmax (tmax) [Pharmacokinetics]
Samples will also be collected until 90 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Area under the concentration-time curve (AUC) from time zero to time "t" [Pharmacokinetics]
Samples will also be collected until 90 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
AUC from time zero to infinity (AUC∞) [Pharmacokinetics]
Samples will also be collected until 90 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
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