Overview

A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules in Subjects With Schizophrenia, Schizoaffective Disorder

Status:
Recruiting

Trial end date:
2021-01-31

Target enrollment:

Participant gender:

Summary

Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia. Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.

Phase:

Phase 2

Details

Lead Sponsor:

Lyndra Inc.

Collaborator:

Worldwide Clinical Trials