Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers With Induced Hypoxia

Outcome Measures

Primary Outcomes (2)

Sequence matched median PaO2 per dose cohort comparing TSC vs PBO
Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures
Up to 10 ± 1 minutes after final VO2 max
Sequence matched median VO2 per dose cohort comparing TSC vs PBO
Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures
Up to 33 minutes (achievement of peak wattage)

Secondary Outcomes (2)

Effect of TSC on Median Oxygen Saturation
Up to 33 minutes (achievement of peak wattage)
Effect of TSC on Median Serum Lactate Concentration
Up to 33 minutes (achievement of peak wattage)

Study Arms (3)

0.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Drug: Trans Sodium Crocetinate

1.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Drug: Trans Sodium Crocetinate

2.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

Interventions

Trans Sodium CrocetinateDrug

Single IV bolus

0.5 mg/kg Trans Sodium Crocetinate1.5 mg/kg Trans Sodium Crocetinate2.5 mg/kg Trans Sodium Crocetinate

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy males and females ages 18-40
Non-smoking

Sponsors & Collaborators

Diffusion Pharmaceuticals Inc
Industrylead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 22710, United States

MeSH Terms

Interventions

trans-sodium crocetinate

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

September 8, 2021

Study Start

November 9, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (3)

0.5 mg/kg Trans Sodium Crocetinate

1.5 mg/kg Trans Sodium Crocetinate

2.5 mg/kg Trans Sodium Crocetinate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (3)

0.5 mg/kg Trans Sodium Crocetinate

1.5 mg/kg Trans Sodium Crocetinate

2.5 mg/kg Trans Sodium Crocetinate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations