drugset / Trial / NCT06878833
A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and management of schizophrenia and schizoaffective disorder. This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.
Timeline
- Start
- 2025-04-18
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 2 mg | Oral |
| Subject | Risperidone | Other / unclassified | 4 mg | Oral |
| Subject | Risperidone | Other / unclassified | 6 mg | Oral |
| Subject | Risperidone | Other / unclassified | 15 mg | Oral |
| Subject | Risperidone | Other / unclassified | 30 mg | Oral |
| Subject | Risperidone | Other / unclassified | 45 mg | Oral |