NCT06442462

Study of SPG302 in Adults With Schizophrenia

A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Spinogenix · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

Detailed description

This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks. This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SPG302	small synthetic molecule
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-06-04
• Last updated: 2026-02-06

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study