Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-03-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Diffusion Pharmaceuticals Inc
• Treatments: Trans-sodium crocetinate

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