drugset / Trial / NCT05421429

KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

NCT05421429 ↗

Phase 2 Completed 24 enrolled Suzhou Alphamab Co., Ltd.
Non-randomizedSequentialOpen-labelPrevention

Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).

Timeline

Start
2022-07-07
Primary completion
2024-01-17
Completion
2024-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject KN057 Unknown — Subcutaneous

Indications