NCT05867914

Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD

A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety, Tolerability, and Functionality of 3P-100 in Subjects With PH-ILD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Third Pole Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

A trial to evaluate the safety, tolerability, and functionality of 3P-100, in subjects with Pulmonary Hypertension (PH) accompanying Interstitial Lung Disease (ILD), PH-ILD

Detailed description

This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO (2 mg/hr and 6 mg/hr) for the treatment of subjects with PH-ILD. All subjects will use the 3P-100 device and receive iNO (2 mg/hr and 6 mg/hr) via the 3P-100 device, aiming for \~4-4.5 hours of treatment across both device settings.

Conditions

• Hypertension, Pulmonary
• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DEVICE	Inhaled Nitric Oxide (iNO)	eNOfit system delivering iNO

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-02-10
• Completion: 2024-03-29
• First posted: 2023-05-22
• Last updated: 2024-02-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study