SchizophreniaPhase 1Affinity-1NCT04306146
Study of CAD-9303 in Subjects With Schizophrenia
A Phase 1 study testing CAD-9303 in people with Schizophrenia, run by Cadent Therapeutics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CAD-9303
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2020to 24 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Research
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053
About this study
Official 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
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.
Read the 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
- Being tested
- CAD-9303, Placebos
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-9303Drug
Capsules filled with CAD-9303 from 3 mg up to 1000 mg.
PlacebosDrug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CAD-9303 |
| Placebo | Placebo comparator | Matching placebo will be provided in capsules and administered as a single or multiple dose(s). Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability of CAD-9303 in participants with schizophrenia and normal healthy volunteers (NHV)
Incidence of Adverse Events
Measured: Day 1 through Day 7 Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start28 Feb 2020
- Primary completion22 Sep 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadent Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306146
- Sponsor's protocol ID
- CAD9303-101
- Acronym
- Affinity-1
- Status last verified
- Dec 2021
- First submitted
- 10 Mar 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04306146
- Acronym / sponsor ID
- Affinity-1 / CAD9303-101
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cadent TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD-9303 | Experimental | Drug: CAD-9303Capsules 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. |
| Placebo | Placebo comparator | Drug: PlacebosMatching placebo will be provided in capsules and administered as a single or multiple dose(s). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD-9303Capsules filled with CAD-9303 from 3 mg up to 1000 mg. | Drug | CAD-9303 |
| PlacebosCapsules | Drug | Placebo |
Primary outcome
Assess safety and tolerability of CAD-9303 in participants with schizophrenia and normal healthy volunteers (NHV)
Time frame: Day 1 through Day 7 Follow-up
Incidence of Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAD-9303 in people with Schizophrenia, run by Cadent Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety and tolerability of CAD-9303 in participants with schizophrenia and normal healthy volunteers (NHV) (time frame: Day 1 through Day 7 Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.