drugset / Trial / NCT07484204
Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.
Timeline
- Start
- 2026-07
- Primary completion
- 2028-07
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 45 mg | — |
| Subject | Cariprazine | Small molecule | 90 mg | — |
| Subject | Cariprazine | Small molecule | 135 mg | — |
| Subject | Cariprazine | Small molecule | 180 mg | — |