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

NCT05036980 | Completed Phase 1 FDA Drug

• 1 other identifier: 200-302
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteers With Induced Hypoxia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Effect of TSC on Median Oxygen Saturation

  Up to 33 minutes (achievement of peak wattage)

• Effect of TSC on Median Serum Lactate Concentration

  Up to 33 minutes (achievement of peak wattage)

Study Arms (3)

0.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

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

1.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

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

2.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

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

Interventions

Trans Sodium Crocetinate DRUG

Single IV bolus

0.5 mg/kg Trans Sodium Crocetinate; 1.5 mg/kg Trans Sodium Crocetinate; 2.5 mg/kg Trans Sodium Crocetinate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females ages 18-40
• Non-smoking
• 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.
• 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

You may not qualify if:

• Allergy to study medication
• Pregnant or breast feeding
• Received investigational medicine (IMP) within past 30 days
• VO2 max \< 35 mL/kg/min (male), \< 30 mL/kg/min (female) at screening
• Abnormal pulmonary function testing at screening
• Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
• History of ongoing alcohol or substance abuse
• Known cardiovascular disease, including treated or untreated hypertension
• Respiratory disease and/or any other significant medical condition, including psychiatric disorders
• Clinically significant abnormality on ECG per PI discretion
• Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
• Plasma donation within 7 days prior to screening
• Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
• History of smoking
• Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 22710, United States

Location

MeSH Terms

Interventions

trans-sodium crocetinate

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: September 8, 2021
• Study Start: November 9, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 10, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)