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

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ClinicalTrials.gov Identifier: NCT00886353
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : December 31, 2009
Sponsor:
Information provided by:
Apeiron Biologics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Diseases Cardiovascular Diseases Kidney Diseases Cancer Diseases Biological: APN01 Other: Placebo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers
Study Start Date : April 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: APN01
Healthy volunteers will receive APN01
 Biological: APN01
APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.
Placebo Comparator: Placebo
Physiological saline administrated i.v.
 Other: Placebo
Physiological saline administrated i.v.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability profile of APN01 when administered as a single dose / multiple dose i.v. in healthy volunteers. Measures: Blood chemistry, Hematology, Urinalysis, Adverse events, Vital signs including blood pressure, pulse, respiratory rate, ECG [ Time Frame: 31 Days ]

Secondary Outcome Measures :
  1. To obtain pharmacokinetic and pharmacodynamic data for APN01 and to investigate potential immunogenicity of APN01. Measures: Systemic rhACE2 concentration and activity, potential humoral immune response, Angiotensin II and Angiotensin 1-7 plasma levels. [ Time Frame: 31 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • Age ≥18 years
  • Use of acceptable form of birth control
  • Willing to comply with study protocol
  • No significant background illness
  • Signed informed consent form

Exclusion Criteria:

  • Significant hematological, renal, hepatic, metabolic, psychiatric or pulmonary diseases.
  • Heart disease or elevated blood pressure.
  • Any other significant disease that could interfere with the subject's ability to complete the protocol
  • History of alcohol or drug abuse
  • Abnormal urinalysis
  • Pregnant or lactating female subjects
  • Use of anticoagulants or antihypertensive drugs, particularly drugs interfering with the renin-angiotensin-aldosterone system, Obesity or anorexia (BMI <18 or >30)
  • History of malignancy, except basal cell carcinoma of the skin, Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or positive serology testing in the study screening procedures (except indicating immunization)
  • Participation in a clinical trial within the last 30 days

  • Any of the following laboratory abnormalities:

    • WBC 15% outside of normal limits
    • Hemoglobin 15% outside of normal limits
    • Platelets 15% outside of normal limits
    • Aspartate transferase (AST) or alanine transferase (ALT) above 15% outside of normal limits
    • Alkaline phosphatase above 15% outside of normal limits
    • Urea above 15% outside of normal limits
    • Creatinine above 15% outside of normal limits.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886353


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Apeiron Biologics
Investigators
Principal Investigator: Stephan Kraehenbuehl, Prof. Dr. University Hospital, Basel, Switzerland
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Krähenbühl, Chefarzt klinische Pharmakologie & Toxikologie, Universitätsspital 4031 Basel
ClinicalTrials.gov Identifier: NCT00886353     History of Changes
Other Study ID Numbers: APN01-1-01
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: December 31, 2009
Last Verified: December 2009

Keywords provided by Apeiron Biologics:
RAS
ACE2
Cardiovascular
 Pulmonary
Angiotensin II
Angiotensin 1-7

Additional relevant MeSH terms:
Lung Diseases
Cardiovascular Diseases
Kidney Diseases
Respiratory Tract Diseases
Urologic Diseases