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2.5 mg/kg Trans Sodium Crocetinate for Interstitial Lung Disease (ILD-DLCO Trial)

Phase 2
Waitlist Available
Research Sponsored by Diffusion Pharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes

Summary

This trial is testing a drug called TSC to see if it can help people aged 30-85 with Interstitial Lung Disease. The drug might improve how well their lungs transfer oxygen, making it easier for them to breathe and feel less tired.

Eligible Conditions
  • Interstitial Lung Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
Secondary study objectives
Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD
Change from baseline in HRR after each 6MWT
Change from baseline in the Borg Scale after the 6MWT

Side effects data

From 2021 Phase 1 & 2 trial • 25 Patients • NCT04573322
50%
Interstitial Lung Disease
17%
Congestive Cardiomyopathy
17%
Dyspepsia
17%
Hernial Eventration
17%
Pneumonia Bacterial
17%
Urinary Tract Infection Fungal
17%
Electrocardiogram QT Prolonged
17%
Hiatus Hernia
17%
Nausea
17%
Vomiting
17%
Depression
17%
Urinary Retention
17%
Pulmonary Hypertension
17%
Respiratory Failure
17%
Hepatic Steatosis
17%
Hepatocellular Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in 0.25 mg/kg
Lead-in 0.50 mg/kg
Lead-in 1.0 mg/kg
Lead-in 1.5 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2.5 mg/kg Trans Sodium CrocetinateExperimental Treatment1 Intervention
Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive a single IV bolus dose of 7 mL Normal Saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trans Sodium Crocetinate
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Diffusion Pharmaceuticals IncLead Sponsor
8 Previous Clinical Trials
218 Total Patients Enrolled
~5 spots leftby Nov 2025
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