To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104
Status:
Not yet recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity,
pharmacokinetics, pharmacodynamics, and efficacy of KP104 in complement inhibitor-naïve
subjects with PNH. The study will be conducted in 2 parts. Part 1 is a dose-selection study
to assess escalating doses and varying dose intervals of KP104. Part 2 is a proof-of-concept
(POC) study assessing the efficacy of the optimal intravenous (IV) loading dose followed by
the optimal maintenance dose and regimen of KP104.