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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886353
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : December 31, 2009
Information provided by:
Apeiron Biologics

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 22, 2009
Last Update Posted Date December 31, 2009
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
Official Title  ICMJE Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Diseases
  • Cardiovascular Diseases
  • Kidney Diseases
  • Cancer Diseases
Intervention  ICMJE
  • Biological: APN01
    APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.
  • Other: Placebo
    Physiological saline administrated i.v.
Study Arms  ICMJE
  • Active Comparator: APN01
    Healthy volunteers will receive APN01
    Intervention: Biological: APN01
  • Placebo Comparator: Placebo
    Physiological saline administrated i.v.
    Intervention: Other: Placebo
Publications * Haschke M, Schuster M, Poglitsch M, Loibner H, Salzberg M, Bruggisser M, Penninger J, Krähenbühl S. Pharmacokinetics and pharmacodynamics of recombinant human angiotensin-converting enzyme 2 in healthy human subjects. Clin Pharmacokinet. 2013 Sep;52(9):783-92. doi: 10.1007/s40262-013-0072-7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 21, 2009)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00886353
Other Study ID Numbers  ICMJE APN01-1-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. Dr. Krähenbühl, Chefarzt klinische Pharmakologie & Toxikologie, Universitätsspital 4031 Basel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Apeiron Biologics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephan Kraehenbuehl, Prof. Dr. University Hospital, Basel, Switzerland
PRS Account Apeiron Biologics
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP