Mild Respiratory DistressPhase 1EXTEND-1bNCT06658535
A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress
A Phase 1 study testing dodecafluoropentane (0.025 mL/kg), dodecafluoropentane (0.032 mL/kg) and dodecafluoropentane (0.050 mL/kg) in people with Mild Respiratory Distress, run by NuvOx LLC at 2 sites in Canada.
Trial summary
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Respiratory Distress
- What is being tested?
- dodecafluoropentane (0.025 mL/kg), dodecafluoropentane (0.032 mL/kg) and dodecafluoropentane (0.050 mL/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Mar 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
- Admitted to a hospital with symptoms of mild RD
- Signed informed consent obtained from the subject or subject's legally authorized representative
- Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28
Who cannot join
- Presence of extracorporeal membrane oxygenation
- Unstable hypertension
- History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
- Presence of pulmonary embolism at baseline
- Evidence of right ventricular heart failure
- Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
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- Inability to comply with the study procedures
- Currently pregnant or breastfeeding
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Grey Nun Community Hospital
Edmonton, Alberta, T6L 5X8
Anushka Jayasekara, 587-590-5295, Anushka.Jayasekara@covenanthealth.ca
Janek Senaratne, MD
- Recruiting
Hôpital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Danaë Tassy, PhD, 514-252-3400 ext. 4679, danae.tassy.cemtl@ssss.gouv.qc.ca
François Marquis, MD
About this study
Official title: Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.
- Conditions
- Mild Respiratory Distress
- Being tested
- dodecafluoropentane (0.025 mL/kg), dodecafluoropentane (0.032 mL/kg), dodecafluoropentane (0.050 mL/kg)
- Keywords
- respiratory distress
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dodecafluoropentane (0.025 mL/kg)Drug
Also called NanO2™
dodecafluoropentane (0.025 mL/kg)
dodecafluoropentane (0.032 mL/kg)Drug
Also called NanO2™
dodecafluoropentane (0.032 mL/kg)
dodecafluoropentane (0.050 mL/kg)Drug
Also called NanO2™
dodecafluoropentane (0.050 mL/kg)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0.025 | Experimental | Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours. Receives: Drug: dodecafluoropentane (0.025 mL/kg) |
| Cohort 0.032 | Experimental | Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours. Receives: Drug: dodecafluoropentane (0.032 mL/kg) |
| Cohort 0.050 | Experimental | Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours. Receives: Drug: dodecafluoropentane (0.050 mL/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.
Measured: 28 Days
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Cumulative incidence of adverse events and serious adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Respiratory DistressStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Up to six subjects will be enrolled at each dose level
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuvOx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658535
- Sponsor's protocol ID
- EXTEND 1b
- Other IDs
- 75A50123C00034
- Acronym
- EXTEND-1b
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
- ClinicalTrials.gov ID
- NCT06658535
- Acronym / sponsor ID
- EXTEND-1b / EXTEND 1b
- Conditions
- Mild Respiratory Distress
- Keywords
- respiratory distress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NuvOx LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 2024 (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.
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Up to six subjects will be enrolled at each dose level
| Arm | Type | Receives |
|---|---|---|
| Cohort 0.025 | Experimental | Drug: dodecafluoropentane (0.025 mL/kg)Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours. |
| Cohort 0.032 | Experimental | Drug: dodecafluoropentane (0.032 mL/kg)Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours. |
| Cohort 0.050 | Experimental | Drug: dodecafluoropentane (0.050 mL/kg)Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
- Admitted to a hospital with symptoms of mild RD
- Signed informed consent obtained from the subject or subject's legally authorized representative
- Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28
Key exclusion criteria (10 listed)
- Presence of extracorporeal membrane oxygenation
- Unstable hypertension
- History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
- Presence of pulmonary embolism at baseline
- Evidence of right ventricular heart failure
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 |
|---|---|---|
| dodecafluoropentane (0.025 mL/kg)Also: NanO2™dodecafluoropentane (0.025 mL/kg) | Drug | Cohort 0.025 |
| dodecafluoropentane (0.032 mL/kg)Also: NanO2™dodecafluoropentane (0.032 mL/kg) | Drug | Cohort 0.032 |
| dodecafluoropentane (0.050 mL/kg)Also: NanO2™dodecafluoropentane (0.050 mL/kg) | Drug | Cohort 0.050 |
Primary outcome
Maximum Tolerated Dose
Time frame: 28 Days
To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dodecafluoropentane (0.025 mL/kg), dodecafluoropentane (0.032 mL/kg) and dodecafluoropentane (0.050 mL/kg) in people with Mild Respiratory Distress, run by NuvOx LLC at 2 sites in Canada.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NuvOx Pharma (520-624-6688, EXTEND_Clinical@nuvoxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 28 Days). 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 28 Jan 2026.