NCT06878833

A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	LYN-005 (risperidone)	long-acting oral (LAO) capsule
DRUG	Placebo for LYN-005	capsule
DRUG	IR Risperidone	tablets
DRUG	Placebo for IR Risperidone	tablets

Timeline

• Start date: 2025-04-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-17
• Last updated: 2025-04-08

Regulatory

• FDA-regulated drug study