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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: Completed Phase 1 study of Healthy Subjects, sponsored by Diffusion Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trans-Sodium Crocetinate
Study Locations (1)
Kansas
- Altasciences Clinical Kansas Inc - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2021-03-25 |
| Phase | Phase 1 |
What the finished NCT04808622 record still lists
NCT04808622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04808622's enrollment target sits among peer trials
30 38th of 69 higher than 30 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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