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

Primary Purpose

Pulmonary Diseases, Cardiovascular Diseases, Kidney Diseases

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

APN01

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Diseases focused on measuring RAS, ACE2, Cardiovascular, Pulmonary, Angiotensin II, Angiotensin 1-7

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

APN01

Placebo

Arm Description

Healthy volunteers will receive APN01

Physiological saline administrated i.v.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00886353

First Posted

April 20, 2009

Last Updated

December 30, 2009

Sponsor

Apeiron Biologics

1. Study Identification

Unique Protocol Identification Number

NCT00886353

Brief Title

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

Official Title

Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Apeiron Biologics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Diseases, Cardiovascular Diseases, Kidney Diseases, Cancer Diseases

Keywords

RAS, ACE2, Cardiovascular, Pulmonary, Angiotensin II, Angiotensin 1-7

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

APN01

Arm Type

Active Comparator

Arm Description

Healthy volunteers will receive APN01

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Physiological saline administrated i.v.

Intervention Type

Biological

Intervention Name(s)

APN01

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Physiological saline administrated i.v.

Primary Outcome Measure Information:

Title

Time Frame

31 Days

Secondary Outcome Measure Information:

Title

Time Frame

31 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan Kraehenbuehl, Prof. Dr.

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

23681967

Citation

Haschke M, Schuster M, Poglitsch M, Loibner H, Salzberg M, Bruggisser M, Penninger J, Krahenbuhl S. Pharmacokinetics and pharmacodynamics of recombinant human angiotensin-converting enzyme 2 in healthy human subjects. Clin Pharmacokinet. 2013 Sep;52(9):783-92. doi: 10.1007/s40262-013-0072-7.

Results Reference

derived

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

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