A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress (EXTEND-1b)

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Respiratory Distress
• Intervention / Treatment: Drug: dodecafluoropentane (0.025 mL/kg); Drug: dodecafluoropentane (0.032 mL/kg); Drug: dodecafluoropentane (0.050 mL/kg)

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: NuvOx Pharma; Phone Number: 520-624-6688; Email: EXTEND_Clinical@nuvoxpharma.com

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6L 5X8
      • Recruiting
      • Grey Nun Community Hospital
      • Contact: Anushka Jayasekara; Phone Number: 587-590-5295; Email: Anushka.Jayasekara@covenanthealth.ca
      • Principal Investigator: Janek Senaratne, MD
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve Rosemont
      • Principal Investigator: François Marquis, MD
      • Contact: Danaë Tassy, PhD; Phone Number: 4679 514-252-3400; Email: danae.tassy.cemtl@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 0.025; Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.	Drug: dodecafluoropentane (0.025 mL/kg); dodecafluoropentane (0.025 mL/kg); Other Names: NanO2™
Experimental: Cohort 0.032; Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.	Drug: dodecafluoropentane (0.032 mL/kg); dodecafluoropentane (0.032 mL/kg); Other Names: NanO2™
Experimental: Cohort 0.050; Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.	Drug: dodecafluoropentane (0.050 mL/kg); dodecafluoropentane (0.050 mL/kg); Other Names: NanO2™

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Respiratory Rate Oxygenation (ROX) Index score	Change in ROX Index from baseline. ROX Index = 100*(SaO2/FiO2)/respiratory rate	24 hours
World Health Organization (WHO) 8-point scale for clinical assessments	Evaluate distribution of WHO 8-point ordinal scale at various time points throughout the study. Clinical assessment assigning clinical status of increasing severity from 1 to 8.	28 days
NanO2 Oxygenation	Duration of NanO2 oxygenation response as measured by pulse oximetry	2 days
Determine the effects of NanO2 on PaO2 measurements	Comparisons of PaO2 measurements before, during and after NanO2 infusions	2 days

Collaborators and Investigators

• Sponsor: NuvOx LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: respiratory distress
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea; perfluoropentane
• Other Study ID Numbers: EXTEND 1b; 75A50123C00034 (Other Grant/Funding Number: ASPR-BARDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes