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

NCT06658535 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: EXTEND 1b75A50123C00034
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Respiratory Distress

Keywords

respiratory distress

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.

  28 Days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  28 days

Other Outcomes (4)

• Change in Respiratory Rate Oxygenation (ROX) Index score

  24 hours

• World Health Organization (WHO) 8-point scale for clinical assessments

  28 days

• NanO2 Oxygenation

  2 days

Study Arms (3)

Cohort 0.025

EXPERIMENTAL

Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.

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.

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.

Drug: dodecafluoropentane (0.050 mL/kg)

Interventions

dodecafluoropentane (0.032 mL/kg) DRUG

dodecafluoropentane (0.032 mL/kg)

Also known as: NanO2™

Cohort 0.032

dodecafluoropentane (0.025 mL/kg) DRUG

dodecafluoropentane (0.025 mL/kg)

Also known as: NanO2™

Cohort 0.025

dodecafluoropentane (0.050 mL/kg) DRUG

dodecafluoropentane (0.050 mL/kg)

Also known as: NanO2™

Cohort 0.050

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NuvOx LLC: lead

Study Sites (2)

Grey Nun Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

RECRUITING

Hôpital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Dyspnea

Interventions

perfluoropentane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

NuvOx Pharma

CONTACT

520-624-6688; EXTEND_Clinical@nuvoxpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to six subjects will be enrolled at each dose level

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 26, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CA (2)