NCT05018403

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

A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aptarion Biotech AG · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2021-08-24
• Last updated: 2022-01-12

Locations

1 site across 1 country: Germany