Clinical trial · Interventional
Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers
NCT00886353CI-TRIAL-00002951completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Diseases | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Kidney Diseases | — | UNRESOLVED | — |
| Pulmonary Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APN01 | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- APN01
- description
- Healthy volunteers will receive APN01
- interventionNames
- Biological: APN01
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Physiological saline administrated i.v.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHaschke 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 23681967