Study of CAD-9303 in Subjects With Schizophrenia

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cadent Therapeutics

Criteria

Key Inclusion Criteria:

• For SAD Cohorts: able to tolerate washout from antipsychotic medications for the duration of the planned cohort.

• For MAD Cohorts: not taking an antipsychotic medication at screening and throughout participation in the study or taking one antipsychotic medication at least 6 weeks prior to screening and as a concomitant antipsychotic medication throughout participation in the study.

• Diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria with duration of illness > 1 year since diagnosis.

• Clinical history of minimal, stable positive symptoms while under treatment with a stable psychotropic regimen.

Key Exclusion Criteria:

• Abnormal findings on screening safety EEG or lifetime history of seizures or stroke.

• Meets current criteria of any psychiatric diagnosis other than schizophrenia, or lifetime history of any psychiatric diagnosis other than schizophrenia based upon the Mini International Neuropsychiatric Interview (MINI).

• Participants with moderate to severe extrapyramidal symptoms including tardive dyskinesia (Simpson-Angus Scale>6, any Abnormal Involuntary Movement Scale (AIMS) Item 1-7 >2), and akathisia (Barnes Akathisia Rating Scale [BARS] Item 4 ≥1).