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

This study has been completed.
Sponsor:
Information provided by:
Apeiron Biologics
ClinicalTrials.gov Identifier:
NCT00886353
First received: April 20, 2009
Last updated: December 30, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Pulmonary Diseases
Cardiovascular Diseases
Kidney Diseases
Cancer Diseases
Biological: APN01
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Apeiron Biologics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Apeiron Biologics

Additional 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
Study First Received: April 20, 2009
Last Updated: December 30, 2009
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on April 17, 2014