Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06226064
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-12-07
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of VES001 in Healthy Participants
Sponsor:
Vesper Biotechnologies ApS
Organization:
Vesper Biotechnologies ApS
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Single and Multiple Ascending Dose Study in Healthy Volunteers and Asymptomatic GRN Mutation Carriers to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of VES001
Status:
COMPLETED
Status Verified Date:
2024-08
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:
SORT-IN-1
Brief Summary:
This is a Phase 1 randomized placebo-controlled double-blind study to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of single and multiple doses of VES001 in a two part followed by a multicenter open-label Phase 1b study in asymptomatic GRN mutation carriers
Part A will evaluate the safety tolerability PK and PD of single doses of VES001 in healthy volunteers
Part B will evaluate the safety tolerability PK and PD of multiple doses of VES001 in healthy volunteers
Part A will evaluate the safety tolerability PK and PD of single doses of VES001 in healthy volunteers
Part B will evaluate the safety tolerability PK and PD of multiple doses of VES001 in healthy volunteers
Detailed Description:
Part A will include six cohorts with eight participants per cohort Participants in each cohort will be randomised in a 62 ratio VES001 vs placebo
Part B will include three cohorts with ten participants per cohort Participants in each cohort will be randomised in a 82 ratio VES001 vs placebo
Part B will include three cohorts with ten participants per cohort Participants in each cohort will be randomised in a 82 ratio VES001 vs placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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