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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urologic Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 25, 2014