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

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.

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.