Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06674694
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: