Status:
COMPLETED
Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
Lead Sponsor:
Apeiron Biologics
Conditions:
Pulmonary Diseases
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00886353
Start Date
April 1 2009
End Date
December 1 2009
Last Update
December 31 2009
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031