Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
Condition: Healthy Subjects
Intervention: Trans-Sodium Crocetinate; Placebo
Intervention description: TSC given as a one-time IV bolus injection; Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
Intervention MeSH terms: Trans-sodium crocetinate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Transcutaneous oximetry

Summary:

      Randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study.

      Subjects will be randomized to TSC or placebo to determine the effect of Trans Sodium
      Crocetinate (TSC) on Transcutaneous Oximetry Measurements (tcpO2) following a single
      administration of TSC in subjects breathing oxygen (O2).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female, age 18-50

          2. Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours

          3. Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to
             testing on the day of the Treatment Visit

          4. Subject is able to communicate effectively with the Investigator and to comply with
             all study requirements, restrictions, and directions from the study staff

          5. 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 (e.g. condom and spermicide), during the study and at least 30
             days after the last dose of study drug. Females of non-childbearing potential should
             be surgically sterile or at least one year post-menopausal.

          6. Males who engage in sexual activity that has the risk of pregnancy must agree to use a
             double barrier method (e.g. condom and spermicide) 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 breastfeeding

          3. Current smoker and/or any nicotine use within 4 hours of the start of tcpO2
             procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine
             patches

          4. Body Mass Index (BMI) > 30

          5. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg),
             or Hepatitis C Antibody (HCVAb)

          6. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days
             prior to screening

          7. Plasma donation within 7 days prior to screening

          8. Treatment with an investigational drug within 30 days or 5 times the half-life
             (whichever is longer) prior to screening

          9. Any skin condition on limbs to be tested that could impair testing (rash, wound, prior
             radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)

         10. Known cardiovascular disease, including treated or untreated hypertension

         11. Significant respiratory disease and/or any other significant medical condition

         12. Subject has an acute illness (gastrointestinal infection, influenza, or known
             inflammatory process) at the Treatment Visit

         13. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and
             enrollment)

         14. Concomitant medications used to treat a diagnosed medical condition

         15. Subject who, for any reason, is deemed by the Investigator to be unsuitable for the
             study; or has any condition that would interfere with the evaluation of tissue oxygen
             measurements or PK of the investigational drug; or is otherwise unable to comply with
             the protocol