At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Trans-Sodium Crocetinate +1 moredrug
Likely dose
Placebo 7 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Pharmacodynamic Study of Trans Sodium Crocetinate Utilizing Transcutaneous Oximetry Measurement in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Trans-Sodium Crocetinate and Placebo for Healthy Subjects. Completed, enrolled 30 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMar 2021
Primary CompletionMar 2021
First PostedMar 2021
Study CompletionMar 2021
TodayJul 2026
First PostedMar 22, 2021
Enrollment StartMar 17, 2021
Primary CompletionMar 21, 2021
Study CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 4 daysPosted 5.3 years ago
Interventions
Trans-Sodium Crocetinatedrug
TSC given as a one-time IV bolus injection
Placebodrug
Placebo normal saline given as a one-time 7 mL one-time IV bolus injection