drugset
drugset / Trial / NCT04808622

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

NCT04808622 ↗

Phase 1 Completed 30 enrolled Diffusion Pharmaceuticals Inc
RandomizedParallel-groupQuadruple-blindBasic science

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).

Timeline

Start
2021-03-17
Primary completion
2021-03-21
Completion
2021-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Trans Sodium Crocetinate Other / unclassified 0.5 mg/kg Intravenous
Subject Trans Sodium Crocetinate Other / unclassified 1 mg/kg Intravenous
Subject Trans Sodium Crocetinate Other / unclassified 1.5 mg/kg Intravenous
Subject Trans Sodium Crocetinate Other / unclassified 2 mg/kg Intravenous
Subject Trans Sodium Crocetinate Other / unclassified 2.5 mg/kg Intravenous

Indications

No indication recorded.