Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT05441904
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
Sponsor:
Poxel SA
Organization:
Study Overview
Official Title:
A Phase I, Two-part, Single and Optional Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 500 and 750 mg PXL770 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety, tolerability find out the side effects and blood levels of the PXL770.
Detailed Description:
None
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?: