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

NCT04808622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-11

Study results available
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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).

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Diffusion Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Martin K Kankam, MD, PhD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2021-03-21
Completion
2021-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808622 on ClinicalTrials.gov