Study of CAD-9303 in Subjects With Schizophrenia

NCT04306146 | Completed Phase 1 FDA Drug

• 1 other identifier: CAD9303-101
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Assess safety and tolerability of CAD-9303 in participants with schizophrenia and normal healthy volunteers (NHV)

  Incidence of Adverse Events

  Day 1 through Day 7 Follow-up

Study Arms (2)

CAD-9303

EXPERIMENTAL

Capsules of CAD-9303 will be administered as a single or multiple dose(s). The initial dose will be 3 mg up to 1000 mg total daily dose.

Drug: CAD-9303

Placebo

PLACEBO COMPARATOR

Matching placebo will be provided in capsules and administered as a single or multiple dose(s).

Drug: Placebos

Interventions

CAD-9303 DRUG

Capsules filled with CAD-9303 from 3 mg up to 1000 mg.

CAD-9303

Placebos DRUG

Capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cadent Therapeutics: lead

Study Sites (2)

Collaborative Neuroscience Research

Long Beach, California, 90806, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: February 28, 2020
• Primary Completion: September 22, 2021
• Study Completion: November 24, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)