Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers With Induced Hypoxia
• Intervention / Treatment: Drug: Trans Sodium Crocetinate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 22710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females ages 18-40
2. Non-smoking
3. Able to provide informed consent and agree to adhere to all study visits and requirements.
4. 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.
5. Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

1. Allergy to study medication
2. Pregnant or breast feeding
3. Received investigational medicine (IMP) within past 30 days
4. VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening
5. Abnormal pulmonary function testing at screening
6. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
7. History of ongoing alcohol or substance abuse
8. Known cardiovascular disease, including treated or untreated hypertension
9. Respiratory disease and/or any other significant medical condition, including psychiatric disorders
10. Clinically significant abnormality on ECG per PI discretion
11. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
12. Plasma donation within 7 days prior to screening
13. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
14. History of smoking
15. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
16. History of seizures
17. Previous pneumothorax or pneumomediastinum
18. Hypo/Hyperglycemia
19. Diabetes
20. Regularly taking medications which may alter heart rate, blood pressure or cardiac output
21. Previous history of middle ear equalization problems at discretion of PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 mg/kg Trans Sodium Crocetinate; Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.	Drug: Trans Sodium Crocetinate; Single IV bolus
Experimental: 1.5 mg/kg Trans Sodium Crocetinate; Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.	Drug: Trans Sodium Crocetinate; Single IV bolus
Experimental: 2.5 mg/kg Trans Sodium Crocetinate; Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.	Drug: Trans Sodium Crocetinate; Single IV bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequence matched median PaO2 per dose cohort comparing TSC vs PBO	Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures	Up to 10 ± 1 minutes after final VO2 max
Sequence matched median VO2 per dose cohort comparing TSC vs PBO	Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures	Up to 33 minutes (achievement of peak wattage)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of TSC on Median Oxygen Saturation	Comparison of oxygen saturation (SpO2) between the control and experimental exposures	Up to 33 minutes (achievement of peak wattage)
Effect of TSC on Median Serum Lactate Concentration	Comparison of lactate between the control and experimental exposures	Up to 33 minutes (achievement of peak wattage)

Collaborators and Investigators

• Sponsor: Diffusion Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 10, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Trans-sodium crocetinate
• Other Study ID Numbers: 200-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No