NCT04808622

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

Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Pharmacodynamic Study of Trans Sodium Crocetinate Utilizing Transcutaneous Oximetry Measurement in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Diffusion Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Trans-Sodium Crocetinate	TSC given as a one-time IV bolus injection
DRUG	Placebo	Placebo normal saline given as a one-time 7 mL one-time IV bolus injection

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-03-21
• Completion: 2021-03-25
• First posted: 2021-03-22
• Last updated: 2023-07-11
• Results posted: 2023-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study