Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721287
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2023-01-31
Brief Title:
A Phase 1 Randomized Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
Sponsor:
Sparian Biosciences Inc
Organization:
Sparian Biosciences Inc
Study Overview
Official Title:
A Phase 1 Double-Blind Randomized Placebo-Controlled Study Evaluating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of SBS-1000 Administered by Intravenous Infusion to Healthy Adult Subjects
Status:
RECRUITING
Status Verified Date:
2023-01
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:
None
Brief Summary:
This study will be a single-center double-blind randomized placebo-controlled adaptive single ascending dose study
Detailed Description:
This study will be a single-center clinical research unit double-blind placebo-controlled randomized adaptive single-ascending dose study receiving either Investigational Product IP SBS-1000 or placebo IV infusion Up to 56 subjects will be randomized
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000 Each cohort will be comprised of up to 8 subjects randomized 62 IPplacebo A sentinel group of 2 subjects randomized 11 IPplacebo will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort and contingent on the results of ongoing safety evaluation
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic PK assessments in all cohorts Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6 The sampling parameters may be adjusted based on the interim safety review
Once the maximum tolerated dose MTD is established dosing with the MTD or a lower dose as determined by an interim safety review an additional cohort 7 will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring Cohort 7 will be comprised of 8 subjects randomized 62 IPplacebo No sentinel dosing administration will occur in this cohort
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000 Each cohort will be comprised of up to 8 subjects randomized 62 IPplacebo A sentinel group of 2 subjects randomized 11 IPplacebo will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort and contingent on the results of ongoing safety evaluation
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic PK assessments in all cohorts Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6 The sampling parameters may be adjusted based on the interim safety review
Once the maximum tolerated dose MTD is established dosing with the MTD or a lower dose as determined by an interim safety review an additional cohort 7 will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring Cohort 7 will be comprised of 8 subjects randomized 62 IPplacebo No sentinel dosing administration will occur in this cohort
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