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Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

NCT05123755 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-27

No results posted yet for this study

Summary

A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).

Conditions

  • Acute Respiratory Distress Syndrome
  • Viral or Bacterial Infections
  • Pneumonia
  • Pneumonia, Viral
  • Respiratory Infection
  • COVID-19 Acute Respiratory Distress Syndrome

Interventions

DRUG

AV-001 Injection

AV-001 (mpaBr) Cl for Injection 2.5 mg/mL

DRUG

AV-001 Placebo Injection

D-PBS

Sponsors & Collaborators

  • Vasomune Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05123755 on ClinicalTrials.gov