NCT05065645

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19

A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled APN01

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Apeiron Biologics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

APN01 is a soluble recombinant form of the human angiotensin-converting enzyme 2 (rhACE2) that is currently under development as a therapy for corona-virus-disease 2019 (COVID-19). By effectively mimicking ACE2 within the body, APN01 is designed to block the SARS-CoV-2 from binding to the ACE2 receptor and infecting cells while at the same time downregulating the renin-aldosterone-angiotensin system (RAAS) to help prevent inflammation and organ injury - critical components involved in the cytokine storm response. ACE2 is the key entry receptor for the SARS-CoV-2. Competitive binding by exogenous angiotensin-converting enzyme 2 (ACE2) may block viral entry, thereby decreasing viral replication in ACE2 expressing organs and protecting the lungs and distal organs from injury induced by SARS-CoV-2. APN01 has been developed as an IV agent to treat acute lung injury and pulmonary arterial hypertension, and moderate to severe COVID-19 infection. Encouraged by the favorable safety profile of IV APN01, we have developed the nebulized APN01 formulation to deliver the drug directly to the respiratory tract, where the virus is mainly found, decreasing systemic exposure and increasing local pulmonary concentration. APN01 intravenously and as inhalation in preclinical studies has been well tolerated with no overall difference in clinical studies from placebo in human trials to date. This study will investigate nebulized APN01 safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity before stepping forward in proof-of-concept studies in patients with COVID-19.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Angiotensin Converting Enzyme 2	SAD: single dose; MAD: dosage 2x daily for 7 days
DRUG	Sodium chloride	SAD: single dose; MAD: dosage 2x daily for 7 days

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2021-10-04
• Last updated: 2022-09-23

Locations

1 site across 1 country: Austria