Schizophrenia Clinical Trial
— Affinity-1Official title:
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
Verified date | December 2021 |
Source | Cadent Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | November 24, 2021 |
Est. primary completion date | September 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Collaborative Neuroscience Research | Long Beach | California |
United States | Hassman Research Institute | Marlton | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Cadent Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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