NCT05643729

Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ZEO ScientifiX, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline. The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Zofin	Intravenous Infusion (IV) of Zofin
OTHER	Placebo	Intravenous Infusion of sterile saline

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-05-30
• Completion: 2024-08-31
• First posted: 2022-12-09
• Last updated: 2023-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study