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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Respiratory Distress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Up to six subjects will be enrolled at each dose level

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 0.025

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

Group Type EXPERIMENTAL

dodecafluoropentane (0.025 mL/kg)

Intervention Type DRUG

dodecafluoropentane (0.025 mL/kg)

Cohort 0.032

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

Group Type EXPERIMENTAL

dodecafluoropentane (0.032 mL/kg)

Intervention Type DRUG

dodecafluoropentane (0.032 mL/kg)

Cohort 0.050

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

Group Type EXPERIMENTAL

dodecafluoropentane (0.050 mL/kg)

Intervention Type DRUG

dodecafluoropentane (0.050 mL/kg)

Interventions

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dodecafluoropentane (0.025 mL/kg)

Intervention Type DRUG

dodecafluoropentane (0.032 mL/kg)

Intervention Type DRUG

dodecafluoropentane (0.050 mL/kg)

Intervention Type DRUG

Other Intervention Names

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NanO2™ NanO2™ NanO2™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No