Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

NCT ID: NCT05079126

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-05-27

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.

Conditions

Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2.5 mg/kg Trans Sodium Crocetinate

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

Group Type: EXPERIMENTAL

Trans Sodium Crocetinate

Intervention Type: DRUG

Single IV Bolus

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single IV Bolus

Interventions

Trans Sodium Crocetinate

Single IV Bolus

Intervention Type: DRUG

Placebo

Single IV Bolus

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diffusion Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pulmonary Associates, P.A.

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

100-601

Identifier Type: -

Identifier Source: org_study_id