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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
China
Beijing Anding Hospital Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Wei Qi
qiw@kelun.com
028-82339360
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 56
Treatments
Experimental: 20mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Experimental: 40mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Experimental: 80mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Experimental: 160mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Experimental: 240mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Experimental: 320mg dosing group
The starting dose is 20 mg and the obtained research results will determine the adjustment of dosage in subsequent study groups.
Related Therapeutic Areas
Sponsors
Leads: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

This content was sourced from clinicaltrials.gov

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