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Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

NCT05962606 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-18

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are:

* The safety and tolerability of AON-D21 vs placebo.
* The efficacy of AON-D21vs placebo.
* The pharmacokinetics of AON-D21.
* The pharmacodynamics of AON D21.
* To identify biomarkers for patient stratification and analyses in future trials.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

AON-D21

AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.

DRUG

Placebo

Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume.

Sponsors & Collaborators

  • Aptarion Biotech AG

    lead INDUSTRY

Principal Investigators

  • Martin Witzenrath, MD · Critical Care Medicine. Charité Universitätsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2026-03-16
Completion
2026-03-16
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05962606 on ClinicalTrials.gov