drugset / Trial / NCT06253546
Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia. Secondary Objectives: * To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc. * To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose administration. * To monitor the safety and tolerability of multiple doses of oral olanzapine tablets given in the study.
Timeline
- Start
- 2024-03-28
- Primary completion
- 2025-06-12
- Completion
- 2025-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Subject | Olanzapine | Small molecule | 15 mg | Oral |
| Subject | Olanzapine | Small molecule | 20 mg | Oral |
| Subject | TV-44749 | Unknown | 318 mg | Subcutaneous |
| Subject | TV-44749 | Unknown | 425 mg | Subcutaneous |
| Subject | TV-44749 | Unknown | 531 mg | Subcutaneous |