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

Apeiron Biologics22 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Diseases Cardiovascular Diseases Kidney Diseases Cancer Diseases

Interventions

APN01BIOLOGICAL

APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.

PlaceboOTHER

Physiological saline administrated i.v.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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