NCT05421429

KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

An Open, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous (SC) Doses of KN057 in Subjects with Hemophilia a or B, with or Without Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Suzhou Alphamab Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hemophilia

Interventions

Type	Name	Description
BIOLOGICAL	KN057 doseⅠ	KN057 subcutaneous (SC) injection
BIOLOGICAL	KN057 dose Ⅱ	KN057 SC injection
BIOLOGICAL	KN057 dose Ⅲ	KN057 SC injection

Timeline

• Start date: 2022-07-07
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2022-06-16
• Last updated: 2024-12-30

Locations

2 sites across 1 country: China