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Efficacy and Safety Evaluation of BZ371B in ARDS Patients

NCT05384379 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-06-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.

Conditions

  • ARDS
  • ARDS, Human
  • Pulmonary Disease

Interventions

DRUG

Inhaled BZ371B

Intubated patients suffering from ARDS will receive BZ371B in a dose of 12 mg. This will be divided into 2 nebulizations, each with 10 ml. The first nebulization is at a dose of 3 mg and the second at a dose of 9 mg.

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • Biozeus Biopharmaceutical S.A.

    lead INDUSTRY

Principal Investigators

  • Marcelo BP Amato, Phd · Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2023-03-03
Completion
2023-03-03

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384379 on ClinicalTrials.gov