Spots Global Cancer Trial Database for Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
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Trial Identification
Brief Title: Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)
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 ID: NCT00886353
Study Description
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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
University Hospital Basel, Basel, , Switzerland
Contact Details
Name: Stephan Kraehenbuehl, Prof. Dr.
Affiliation: University Hospital, Basel, Switzerland
Role: PRINCIPAL_INVESTIGATOR
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