Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2020-02-28
2021-11-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CAD-9303
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.
CAD-9303
Capsules filled with CAD-9303 from 3 mg up to 1000 mg.
Placebo
Matching placebo will be provided in capsules and administered as a single or multiple dose(s).
Placebos
Capsules
Interventions
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CAD-9303
Capsules filled with CAD-9303 from 3 mg up to 1000 mg.
Placebos
Capsules
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
50 Years
ALL
Yes
Sponsors
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Cadent Therapeutics
INDUSTRY
Responsible Party
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Locations
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Collaborative Neuroscience Research
Long Beach, California, United States
Hassman Research Institute
Marlton, New Jersey, United States
Countries
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Other Identifiers
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CAD9303-101
Identifier Type: -
Identifier Source: org_study_id
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