Trial intelligence / Profile preview

PK/Safety of recAP in Healthy Japanese Subjects

NCT04923282Phase 1Completed

Sponsor
AM-Pharma
Start
May 2021
Primary completion
Jul 2021
Modality
Replacement Enzymes
Countries
1
01

Overview

Phase 1, randomised, double-blind trial of ilofotase alfa in acute kidney injury (AKI), sponsored by AM-Pharma. Primary endpoints: Maximum observed recAP plasma concentration after single dose at 9 days, Time to attain maximum recAP serum concentration after single dose at 9 days and 6 more. Started May 2021; status: completed.

02

Drugs

ilofotase alfa
03

Conditions

acute kidney injury (AKI)

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