Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05203367
Status:
WITHDRAWN
Last Update Posted:
2024-06-20
First Post:
2021-12-04
Brief Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of BAR 502 in Healthy Subjects
Sponsor:
BAR Pharmaceuticals srl
Organization:
BAR Pharmaceuticals srl
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Phase 1 Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Update development program
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center randomized double-blind placebo-controlled single-ascending dose SAD phase 1 study to evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects
Detailed Description:
This clinical trial will be the first-in-Human FiH study of BAR 502
This study is planned to investigate up to 4 dose levels of BAR 502 Each dose level will consist of 8 healthy male and female subjects ratio 11 male female to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo ratio 31 active placebo
The study is designed to meet the following objectives
Primary
To evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects
Secondary
To investigate the pharmacokinetics PK of single-ascending doses of BAR 502 in healthy male and female subjects
To investigate the pharmacodynamics PD of single-ascending doses of BAR 502 in healthy male and female subjects
This study is planned to investigate up to 4 dose levels of BAR 502 Each dose level will consist of 8 healthy male and female subjects ratio 11 male female to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo ratio 31 active placebo
The study is designed to meet the following objectives
Primary
To evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects
Secondary
To investigate the pharmacokinetics PK of single-ascending doses of BAR 502 in healthy male and female subjects
To investigate the pharmacodynamics PD of single-ascending doses of BAR 502 in healthy male and female subjects
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