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

Phase 1

Completed

• Conditions: Pulmonary Diseases; Cardiovascular Diseases; Kidney Diseases; Cancer Diseases
• Interventions: Biological: APN01; Other: Placebo

• Registration Number: NCT00886353
• Lead Sponsor: Apeiron Biologics

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2009-11
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-30
• Last Update Posted: 2009-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APN01	APN01	Healthy volunteers will receive APN01
Placebo	Placebo	Physiological saline administrated i.v.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland