Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-10 @ 2:14 PM
Study NCT ID:
NCT02544061
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2015-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
Sponsor:
Neumedicines Inc.
Organization:
Study Overview
Official Title:
A Phase IIa Open-label, Randomized Study to Compare the Safety, Tolerability and Pharmacokinetics (PK) of NM-IL-12 (rHuIL-12) to Standard of Care in Subjects With Open Surgical Wounds Following Colostomy Takedown
Status:
COMPLETED
Status Verified Date:
2018-11
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 determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.
Detailed Description:
This is a phase IIa open-label, randomized study to compare the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of NM-IL-12 (rHuIL-12) to standard of care in subjects with open surgical wounds following colostomy takedown allowed to heal by secondary intention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| W81XWH-15-2-009 | OTHER_GRANT | USA MED RESEARCH ACQ ACTIVITY | View |