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

NCT00886353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2009-12-31

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

APN01

APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.

OTHER

Placebo

Physiological saline administrated i.v.

Sponsors & Collaborators

  • Apeiron Biologics

    lead INDUSTRY

Principal Investigators

  • Stephan Kraehenbuehl, Prof. Dr. · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • Switzerland

Study Locations

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Entities

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 NCT00886353 on ClinicalTrials.gov