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
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
- Pulmonary Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Cancer Diseases
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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