Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04306146
Status:
COMPLETED
Last Update Posted:
2021-12-15
First Post:
2020-03-10
Brief Title:
Study of CAD-9303 in Subjects With Schizophrenia
Sponsor:
Cadent Therapeutics
Organization:
Cadent Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Affinity-1
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None