NCT04510298

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sirtsei Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SP-624	Oral Capsule
DRUG	Placebo	Oral Capsule

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2020-08-12
• Last updated: 2022-04-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study