NCT05036980

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Diffusion Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers With Induced Hypoxia

Interventions

Type	Name	Description
DRUG	Trans Sodium Crocetinate	Single IV bolus

Timeline

• Start date: 2021-11-09
• Primary completion: 2022-04-08
• Completion: 2022-04-10
• First posted: 2021-09-08
• Last updated: 2022-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study