NCT02544061

NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Neumedicines Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colostomy Stoma

Interventions

Type	Name	Description
BIOLOGICAL	NM-IL-12	single 12 µg unit subcutaneous (SC) dose of NM-IL-12
DRUG	Placebo	single subcutaneous dose

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-31
• Completion: 2018-02-28
• First posted: 2015-09-09
• Last updated: 2018-11-16

Locations

3 sites across 1 country: United States