NCT00886353

Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)

Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Apeiron Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to define the dose for a Phase II study and to investigate safety and tolerability of intravenous administration of recombinant soluble human Angiotensin Converting Enzyme 2 in healthy volunteers.

Detailed description

APN01-1-01 is a placebo controlled double blinded Phase I study composed of a single dose, dose escalation part followed by a multiple dosage part. The first four cohorts (four individuals each) will receive 100, 200, 400 and 800 µg/kg APN01 i.v. or placebo. Cohorts 5 and 6 (three individuals each) will receive three and six i.v. APN01 administrations daily, respectively. Planned dosage of the multiple dose part will be 400 µg/kg.

Conditions

• Pulmonary Diseases
• Cardiovascular Diseases
• Kidney Diseases
• Cancer Diseases

Interventions

Type	Name	Description
BIOLOGICAL	APN01	APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.
OTHER	Placebo	Physiological saline administrated i.v.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-04-22
• Last updated: 2009-12-31

Locations

1 site across 1 country: Switzerland