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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
Stephan Kraehenbuehl, Prof. Dr.
University Hospital, Basel, Switzerland