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

NuvOx Pharma

Status and phase: Enrolling; Phase 1

Conditions: Mild Respiratory Distress

Treatments: Drug: dodecafluoropentane (0.025 mL/kg); Drug: dodecafluoropentane (0.032 mL/kg); Drug: dodecafluoropentane (0.050 mL/kg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06658535

EXTEND 1b

75A50123C00034 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Cohort 0.025

Experimental group

Description:

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

Treatment:

Drug: dodecafluoropentane (0.025 mL/kg)

Cohort 0.032

Experimental group

Description:

Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.

Treatment:

Drug: dodecafluoropentane (0.032 mL/kg)

Cohort 0.050

Experimental group

Description:

Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.

Treatment:

Drug: dodecafluoropentane (0.050 mL/kg)