Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-06 @ 6:29 AM
Study NCT ID:
NCT06932705
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
Sponsor:
Addpharma Inc.
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
Status:
RECRUITING
Status Verified Date:
2025-04
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:
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
Detailed Description:
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy 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?: