NCT05079126

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Diffusion Pharmaceuticals Inc · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.

Conditions

• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Trans Sodium Crocetinate	Single IV Bolus
DRUG	Placebo	Single IV Bolus

Timeline

• Start date: 2021-12-02
• Primary completion: 2022-05-25
• Completion: 2022-05-27
• First posted: 2021-10-15
• Last updated: 2022-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study