Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pulmonary Diseases
- Sponsor
- Apeiron Biologics
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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:
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.(31 days)