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

NCT ID: NCT00886353

Last Updated: 2009-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Diseases Cardiovascular Diseases Kidney Diseases Cancer Diseases

Keywords

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RAS ACE2 Cardiovascular Pulmonary Angiotensin II Angiotensin 1-7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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APN01

Healthy volunteers will receive APN01

Group Type ACTIVE_COMPARATOR

APN01

Intervention Type BIOLOGICAL

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

Placebo

Physiological saline administrated i.v.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Physiological saline administrated i.v.

Interventions

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APN01

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

Intervention Type BIOLOGICAL

Placebo

Physiological saline administrated i.v.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Apeiron Biologics

INDUSTRY

Sponsor Role lead

Responsible Party

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Universitätsspital 4031 Basel

Principal Investigators

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Stephan Kraehenbuehl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 23681967 (View on PubMed)

Other Identifiers

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APN01-1-01

Identifier Type: -

Identifier Source: org_study_id