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First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects

NCT05018403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-12

No results posted yet for this study

Summary

The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

Intravenous 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

Intravenous placebo

Isotonic glucose solution identical in appearance to AON-D21.

Sponsors & Collaborators

  • Aptarion Biotech AG

    lead INDUSTRY

Principal Investigators

  • Manuela Koch, MD · Nuvisan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-01-05
Completion
2022-01-05

Countries

  • Germany

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 NCT05018403 on ClinicalTrials.gov