Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
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ClinicalTrials.gov Identifier: NCT00886353 |
Recruitment Status :
Completed
First Posted : April 22, 2009
Last Update Posted : December 31, 2009
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Diseases Cardiovascular Diseases Kidney Diseases Cancer Diseases | Biological: APN01 Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | April 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
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Active Comparator: APN01
Healthy volunteers will receive APN01
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Biological: APN01
APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v. |
Placebo Comparator: Placebo
Physiological saline administrated i.v.
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Other: Placebo
Physiological saline administrated i.v. |
- 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 ]
- 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. [ Time Frame: 31 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886353
Switzerland | |
University Hospital Basel | |
Basel, Switzerland, 4031 |
Principal Investigator: | Stephan Kraehenbuehl, Prof. Dr. | University Hospital, Basel, Switzerland |
Responsible Party: | Prof. Dr. Krähenbühl, Chefarzt klinische Pharmakologie & Toxikologie, Universitätsspital 4031 Basel |
ClinicalTrials.gov Identifier: | NCT00886353 |
Other Study ID Numbers: |
APN01-1-01 |
First Posted: | April 22, 2009 Key Record Dates |
Last Update Posted: | December 31, 2009 |
Last Verified: | December 2009 |
RAS ACE2 Cardiovascular |
Pulmonary Angiotensin II Angiotensin 1-7 |
Kidney Diseases Cardiovascular Diseases Urologic Diseases |