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NCT04808622 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Subjects, sponsored by Diffusion Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT04808622 is a Phase 1 study of Healthy Subjects that has completed, run by Diffusion Pharmaceuticals. The registered enrollment target is 30 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04808622, a Phase 1 study of Healthy Subjects, has completed, sponsored by Diffusion Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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 Studied

Healthy Subjects

Interventions

  • DRUG Placebo
  • DRUG Trans-Sodium Crocetinate

Study Locations (1)

Kansas

  • Altasciences Clinical Kansas Inc - Overland Park

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-03-17
Est. Completion 2021-03-25
Phase Phase 1

Sponsor

Diffusion Pharmaceuticals

8 total trials

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What the Registry Record Tells You About NCT04808622

The ClinicalTrials.gov registry entry for NCT04808622 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (77% lower). The listed sponsor is Diffusion Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04808622 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT04808622 about?

NCT04808622 is a clinical study titled "Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers". 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 breathin...

What is the current status of trial NCT04808622?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-03-17. Estimated completion is 2021-03-25.

What conditions does trial NCT04808622 study?

This clinical trial studies the following conditions: Healthy Subjects.

What interventions are being tested in trial NCT04808622?

The interventions under investigation include: Placebo (DRUG), Trans-Sodium Crocetinate (DRUG).

Who is sponsoring clinical trial NCT04808622?

This trial is sponsored by Diffusion Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04808622 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.