Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05627648
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2022-11-16
Brief Title:
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
Sponsor:
Kringle Pharma Inc
Organization:
Kringle Pharma Inc
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
Status:
RECRUITING
Status Verified Date:
2023-11
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 purpose of this study is to confirm the efficacy and safety of KP-100LI a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient for voice function improvement therapy in patients with vocal fold scar including vocal fold sulcus
Detailed Description:
None
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