A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress

Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06658535

Acronym

EXTEND-1b

Enrollment

Registered

2024-10-26

Start date

2025-03-13

Completion date

2026-12-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Respiratory Distress

Keywords

respiratory distress

Brief 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.

Interventions

DRUGdodecafluoropentane (0.025 mL/kg)

dodecafluoropentane (0.025 mL/kg)

DRUGdodecafluoropentane (0.032 mL/kg)

dodecafluoropentane (0.032 mL/kg)

DRUGdodecafluoropentane (0.050 mL/kg)

dodecafluoropentane (0.050 mL/kg)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Up to six subjects will be enrolled at each dose level

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose	28 Days	To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.

Secondary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	28 days	Cumulative incidence of adverse events and serious adverse events

Countries

Canada

Contacts

CONTACTNuvOx Pharma

EXTEND_Clinical@nuvoxpharma.com520-624-6688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026