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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pulmonary Diseases, Cardiovascular Diseases, Kidney Diseases, Cancer Diseases

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

31 Days

Safety Issue:

Yes

Principal Investigator

Stephan Kraehenbuehl, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Basel, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

APN01-1-01

NCT ID:

NCT00886353

Start Date:

April 2009

Completion Date:

December 2009

Related Keywords:

  • Pulmonary Diseases
  • Cardiovascular Diseases
  • Kidney Diseases
  • Cancer Diseases
  • RAS
  • ACE2
  • Cardiovascular
  • Pulmonary
  • Angiotensin II
  • Angiotensin 1-7
  • Cardiovascular Diseases
  • Kidney Diseases
  • Lung Diseases
  • Respiration Disorders

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