NCT00886353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 31, 2009

Status Verified

December 1, 2009

Enrollment Period

7 months

First QC Date

April 20, 2009

Last Update Submit

December 30, 2009

Conditions

Pulmonary DiseasesCardiovascular DiseasesKidney DiseasesCancer Diseases

Keywords

RASACE2CardiovascularPulmonaryAngiotensin IIAngiotensin 1-7

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

APN01

ACTIVE COMPARATOR

Healthy volunteers will receive APN01

Biological: APN01

Placebo

PLACEBO COMPARATOR

Physiological saline administrated i.v.

Other: Placebo

Interventions

APN01BIOLOGICAL

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

APN01
PlaceboOTHER

Physiological saline administrated i.v.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 23681967DERIVED

MeSH Terms

Conditions

Lung DiseasesCardiovascular DiseasesKidney Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Stephan Kraehenbuehl, Prof. Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

December 31, 2009

Record last verified: 2009-12

Locations

CH(1)