NCT04306146

Study of CAD-9303 in Subjects With Schizophrenia

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effects on Neurophysiological Biomarkers of CAD-9303 Oral Treatment in Subjects With Schizophrenia and Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Cadent Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will consist of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety, tolerability, and pharmacokinetics of CAD-9303. The first SAD cohort will be in healthy volunteer subjects. The remaining cohorts will be in participants with schizophrenia.

Detailed description

This study will be conducted in two Parts. Part 1 will consist of Single Ascending Dose (SAD) cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety, tolerability, and pharmacokinetics of CAD-9303. Part 2 will consist of Multiple Ascending Dose (MAD) cohorts that will be randomized, double blind, and placebo-controlled to assess the safety, tolerability, and pharmacokinetics of CAD-9303. The effects of CAD-9303 will be explored on event-related potential (ERP), and on sensory and cognitive function. The first SAD cohort will be in healthy volunteer subjects. The remaining cohorts will be in participants with schizophrenia. Participants will meet specified eligibility criteria. SAD Cohorts will be comprised of 8 subjects; 6 subjects will be administered CAD-9303, and 2 subjects will be administered matching placebo. MAD Cohorts will be comprised of 12 subjects; 9 subjects will be administered CAD-9303, and 3 subjects will be administered matching placebo. Potential subjects will undergo a screening period (up to 28 days), baseline assessments on Day -3, -2 and -1, and dosing on Day 1 for SAD and Days 1 - 14 for MAD. A follow-up visit will occur 7 days after the last dose. The total duration of individual subject participation may be up to 5 weeks for SAD and 7 weeks for MAD, depending on the duration of the screening period. The study will assess safety by adverse events, vital signs, laboratory parameters (including chemistry, hematology and urinalysis) and electroencephalogram (EEG); pharmacokinetics of CAD-9303; and exploratory efficacy measures effects on neurophysiological biomarkers, cognitive and negative symptoms.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	CAD-9303	Capsules filled with CAD-9303 from 3 mg up to 1000 mg.
DRUG	Placebos	Capsules

Timeline

• Start date: 2020-02-28
• Primary completion: 2021-09-22
• Completion: 2021-11-24
• First posted: 2020-03-12
• Last updated: 2021-12-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study