Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

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).
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic
      study of Trans Sodium Crocetinate (TSC) in healthy volunteers. The primary objective is to
      determine the effect of TSC on transcutaneous oximetry measurements (tcpO2) following a
      single administration of TSC in subjects breathing oxygen (O2).

      30 healthy volunteers will be randomized to one of 6 treatment groups, to include 5 TSC doses
      (0.5, 1.0, 1.5, 2.0, and 2.5 mg/kg) and placebo normal saline (7 mL). TcpO2 sensors will be
      applied to 4 standardized areas on the lower extremity. Subjects will be placed on O2 via
      simple face mask at 6 L/minute, and will remain on O2 for 70 minutes prior to study drug
      administration. The first 10 minutes will allow for equilibration of O2 levels, and the
      subsequent 60 minutes will serve as the baseline period. TcpO2 values and SpO2 will be
      recorded every 5 minutes during the above periods. At the end of the 70-minute
      equilibration/baseline period, subjects will receive a single IV bolus injection of TSC at a
      dose of 0.5, 1.0, 1.5, 2.0 or 2.5 mg/kg, or placebo. Study drug will be administered in a
      blinded fashion.

      After study drug is administered, subjects will continue on O2 and be evaluated for an
      additional 60 minutes, with tcpO2 and SpO2 recorded at 1, 2, and 5 minutes post-dose, and
      every 5 minutes thereafter.

      Prior to and following study drug administration, PK samples will be obtained pre-dose, and
      1, 10, 30, and 90 minutes post-dose.

      After the 60 minute post-treatment evaluation period, oxygen will be discontinued and the
      tcpO2 sensor electrodes removed. Subjects will remain in the procedure room for an additional
      30 minutes to allow for collection of the 1.5-hour PK blood draw and repeat vital signs.
      Subjects will remain in the clinic overnight for observation and discharged the following
      morning.

      Subjects will be contacted by telephone at 48 hours (+ 2 days) for a safety follow up to
      assess adverse events and new medications.
    

Intervention name(s): Trans-Sodium Crocetinate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TSC given as a one-time IV bolus injection; Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
Other intervention name(s): TSC; 0.9% Sodium Chloride (NaCl)
Intervention MeSH terms: Trans-sodium crocetinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Transcutaneous oximetry