RecruitingPhase 1NCT06674694

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.


Sponsor

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Enrollment

56 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety, tolerability, and blood levels of a long-acting injectable version of brexpiprazole — an antipsychotic medication — in both healthy volunteers and patients with schizophrenia. Long-acting injectables are given every few weeks instead of daily, which can improve medication adherence. **You may be eligible if (Healthy Volunteers)...** - You are between 18 and 65 years old with a BMI between 19 and 26 - You are in good general health and have no plans for pregnancy during and for 1 year after the study - You can communicate clearly with the research team **You may be eligible if (Patients with Schizophrenia)...** - You have a confirmed schizophrenia diagnosis and are currently on stable oral brexpiprazole - Your symptoms are in a stable phase **You may NOT be eligible if...** - You have significant heart, liver, kidney, or blood disorders - You are pregnant, breastfeeding, or planning pregnancy - You are allergic to brexpiprazole or similar medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrexpiprazole long-acting injection

A single injection was administered.


Locations(1)

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, China

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NCT06674694


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