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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AV-001 Injection — DRUG
  AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
• AV-001 Placebo Injection — DRUG
  D-PBS

Study Details

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).

Key Dates

Start date

Dec 20, 2021

Status verified

Sep 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: AV-001 Injection with standard of care (SOC).
  A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) 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). Doses of AV-001 Injection will start with 12.5 μg/kg/day in cohort 1 and are anticipated to increase to 25 μg/kg/day in cohort 2, 56 μg/kg/day in cohort 3 and to be determined (TBD) in cohort 4. The dose for cohort 4 will be determined by the Data Safety Monitoring Board (DSMB) based on emerging data from cohorts 1, 2 and 3.
• Placebo Comparator: AV-001 Placebo Injection with standard of care (SOC).
  A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) 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).

Primary Outcome Measure

Safety and tolerability of multiple doses of IV administrations of AV-001 Injection compared with AV-001 placebo Injection in hospitalized patients with pneumonia due to COVID-19 and/or other respiratory infections. [ Time Frame: Up to Day 60 ]

Locations (5)

Find similar trials in Newport Beach, CA

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