Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-04 @ 3:20 PM
Study NCT ID:
NCT05203367
Status:
WITHDRAWN
Last Update Posted:
2024-06-20
First Post:
2021-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects
Sponsor:
BAR Pharmaceuticals s.r.l.
Organization:
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WITHDRAWN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 1:1, male: female) to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo (ratio 3:1, 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 1:1, male: female) to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo (ratio 3:1, 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:
False
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?: