Interstitial Lung Disease
Conditions
Brief 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.
Interventions
Single IV Bolus
DRUGPlacebo
Single IV Bolus
Sponsors
Diffusion Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD | 60 minutes | 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. |
| Change from baseline in HRR after each 6MWT | 60 minutes | 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. |
| Change from baseline in the Borg Scale after the 6MWT | 60 minutes | 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. |
Countries
United States
Outcome results
None listed