Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Drug: Trans Sodium Crocetinate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, age 30 to 85 years at screening Able to provide informed consent and agree to adhere to all study visits and requirements 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 Established diagnosis of ILD (clinical, radiographic, or histologic) SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air Free of any active cardiovascular or neuromuscular disease, at PI discretion Clinically stable disease with no major medication changes in the last 4 weeks Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months) DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months) Sars-CoV-2 negative at screening Exclusion Criteria: Known allergy to study medication Pregnancy or lactation Current smoker Inability to perform pulmonary function testing Active infection at screening or day of study visit Known pulmonary hypertension (PH) requiring PH-specific treatment AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN Received any investigational medicine (IMP) within past 30 days Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant. Current alcohol or substance abuse Known active or latent hepatitis B or C History of end-stage liver or renal disease Positive COVID test anytime within 3 months of screening. Note: Patients who were previously vaccinated for COVID are allowed History of venous thromboembolic disease History of acute or chronic ophthalmologic conditions currently requiring treatment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.5 mg/kg Trans Sodium Crocetinate<br>Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. | Drug: Trans Sodium Crocetinate<br>* Single IV Bolus<br>|
| Placebo Comparator: Placebo<br>Subjects will receive a single IV bolus dose of 7 mL Normal Saline. | Drug: Placebo<br>* Single IV Bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD | Compare the proportion of patients who achieve a prespecified level of improvement in DLCO 30 minutes after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD | Compare the proportion of patients who achieve a pre-specified level of improvement in 6 minute walk test (6MWT) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms. | 60 minutes | 
| Change from baseline in HRR after each 6MWT | Compare the proportion of patients who achieve a pre-specified level of improvement in heart rate recovery (HRR) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms. | 60 minutes | 
| Change from baseline in the Borg Scale after the 6MWT | Compare the proportion of patients who achieve a pre-specified level of improvement in the Borg dyspnea scale after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms. | 60 minutes |