Healthy Volunteers With Induced HypoxiaPhase 1NCT05036980
Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude
A Phase 1 study testing Trans Sodium Crocetinate in people with Healthy Volunteers With Induced Hypoxia, run by Diffusion Pharmaceuticals Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers With Induced Hypoxia
- What is being tested?
- Trans Sodium Crocetinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 10 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females ages 18-40
- Non-smoking
- Able to provide informed consent and agree to adhere to all study visits and requirements.
- Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
- Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug
Who cannot join
- Allergy to study medication
- Pregnant or breast feeding
- Received investigational medicine (IMP) within past 30 days
- VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening
- Abnormal pulmonary function testing at screening
- Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
Show all 21Show fewer
- History of ongoing alcohol or substance abuse
- Known cardiovascular disease, including treated or untreated hypertension
- Respiratory disease and/or any other significant medical condition, including psychiatric disorders
- Clinically significant abnormality on ECG per PI discretion
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
- Plasma donation within 7 days prior to screening
- Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
- History of smoking
- Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
- History of seizures
- Previous pneumothorax or pneumomediastinum
- Hypo/Hyperglycemia
- Diabetes
- Regularly taking medications which may alter heart rate, blood pressure or cardiac output
- Previous history of middle ear equalization problems at discretion of PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 22710
About this study
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
- Being tested
- Trans Sodium Crocetinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Sodium CrocetinateDrug
Single IV bolus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Trans Sodium Crocetinate |
| 2.5 mg/kg Trans Sodium Crocetinate | Experimental | Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control. Receives: Drug: Trans Sodium Crocetinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 33 minutes (achievement of peak wattage)
Secondary outcomes (2)
Effect of TSC on Median Oxygen Saturation
Comparison of oxygen saturation (SpO2) between the control and experimental exposures
Measured: Up to 33 minutes (achievement of peak wattage)
Effect of TSC on Median Serum Lactate Concentration
Comparison of lactate between the control and experimental exposures
Measured: Up to 33 minutes (achievement of peak wattage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start9 Nov 2021
- Primary completion8 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers With Induced HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diffusion Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036980
- Sponsor's protocol ID
- 200-302
- Status last verified
- Apr 2022
- First submitted
- 30 Jul 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude
- ClinicalTrials.gov ID
- NCT05036980
- Acronym / sponsor ID
- 200-302
- Conditions
- Healthy Volunteers With Induced Hypoxia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Diffusion Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg/kg Trans Sodium Crocetinate | Experimental | Drug: Trans Sodium CrocetinateSubjects 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. |
| 1.5 mg/kg Trans Sodium Crocetinate | Experimental | Drug: Trans Sodium CrocetinateSubjects 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. |
| 2.5 mg/kg Trans Sodium Crocetinate | Experimental | Drug: Trans Sodium CrocetinateSubjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and females ages 18-40
- Non-smoking
- Able to provide informed consent and agree to adhere to all study visits and requirements.
- Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
- Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug
Key exclusion criteria (21 listed)
- Allergy to study medication
- Pregnant or breast feeding
- Received investigational medicine (IMP) within past 30 days
- VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening
- Abnormal pulmonary function testing at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans Sodium CrocetinateSingle IV bolus | Drug | 0.5 mg/kg Trans Sodium Crocetinate, 1.5 mg/kg Trans Sodium Crocetinate, 2.5 mg/kg Trans Sodium Crocetinate |
Primary outcome
Sequence matched median PaO2 per dose cohort comparing TSC vs PBO
Time frame: Up to 10 ± 1 minutes after final VO2 max
Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures
Sequence matched median VO2 per dose cohort comparing TSC vs PBO
Time frame: Up to 33 minutes (achievement of peak wattage)
Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures
2 secondary outcomes
Effect of TSC on Median Oxygen Saturation
Time frame: Up to 33 minutes (achievement of peak wattage)
Effect of TSC on Median Serum Lactate Concentration
Time frame: Up to 33 minutes (achievement of peak wattage)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trans Sodium Crocetinate in people with Healthy Volunteers With Induced Hypoxia, run by Diffusion Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequence matched median PaO2 per dose cohort comparing TSC vs PBO (time frame: Up to 10 ± 1 minutes after final VO2 max). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.