NCT06747416

KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors

A Phase II Multicenter, Open Label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and PK/PD Profile of Multiple Subcutaneous Injection of KN057 in Male Patients with Severe Hemophilia a or Moderate-to-Severe Hemophilia B with or Without Inhibitors

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

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \<1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.

Conditions

• Hemophilia a and B

Interventions

Type	Name	Description
DRUG	KN057	KN057 will be administered subcutaneously once a week.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-09-02
• Completion: 2026-12-31
• First posted: 2024-12-24
• Last updated: 2024-12-24

Regulatory

• FDA-regulated drug study