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Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or Female, age 30 to 85 years at screening. 2. Able to provide informed consent and agree to adhere to all study visits and requirements. 3. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug. 4. Established diagnosis of ILD (clinical, radiographic, or histologic) 5. SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air. 6. Free of any active cardiovascular or neuromuscular disease, at PI discretion. 7. Clinically stable disease with no major medication changes in the last 4 weeks. 8. Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months) 9. DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months) 10. Sars-CoV-2 negative at screening.

Exclusion Criteria:

1. Known allergy to study medication. 2. Pregnancy or lactation. 3. Current smoker. 4. Inability to perform pulmonary function testing. 5. Active infection at screening or day of study visit. 6. Known pulmonary hypertension (PH) requiring PH-specific treatment. 7. AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN. 8. Received any investigational medicine (IMP) within past 30 days. 9. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant. 10. Current alcohol or substance abuse. 11. Known active or latent hepatitis B or C. 12. History of end-stage liver or renal disease. 13. Positive COVID test anytime within 3 months of screening. Note: Patients who were previously vaccinated for COVID are allowed. 14. History of venous thromboembolic disease. 15. History of acute or chronic ophthalmologic conditions currently requiring treatment

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05079126
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Diffusion Pharmaceuticals Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Arms & Interventions

Arms

Experimental: 2.5 mg/kg Trans Sodium Crocetinate

Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.

Placebo Comparator: Placebo

Subjects will receive a single IV bolus dose of 7 mL Normal Saline.

Interventions

Drug: - Trans Sodium Crocetinate

Single IV Bolus

Drug: - Placebo

Single IV Bolus

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pulmonary Associates, P.A., Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates, P.A.

Phoenix, Arizona, 85032

Site Contact

Mark Gotfried, MD

m.gotfried@pulmonaryassociates.com

602-258-4951