drugset
drugset / Trial / NCT05036980

Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

NCT05036980 ↗

Phase 1 Completed 30 enrolled Diffusion Pharmaceuticals Inc
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).

Timeline

Start
2021-11-09
Primary completion
2022-04-08
Completion
2022-04-10

Drugs

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

Indications

No indication recorded.