NCT04822883

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

A Single-arm, Single-blind, Multiple Dose Study to Evaluate Safety and the Effects of RL-007 on Electroencephalograms and Event-related Potentials in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Recognify Life Sciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia

Detailed description

Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.

Conditions

• Cognitive Impairment
• Schizophrenia

Interventions

Type	Name	Description
DRUG	RL-007	Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
DRUG	RL-007 Matching Placebo	Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2021-03-30
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study