Cancer Diseases, Cardiovascular Diseases, Kidney Diseases, Pulmonary Diseases
Conditions
Keywords
RAS, ACE2, Cardiovascular, Pulmonary, Angiotensin II, Angiotensin 1-7
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 2 in healthy volunteers.
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.
Interventions
BIOLOGICALAPN01
APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.
OTHERPlacebo
Physiological saline administrated i.v.
Sponsors
Apeiron Biologics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 31 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 31 days |
Countries
Switzerland
Outcome results
None listed