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NOT YET RECRUITING
NCT06747416
PHASE2

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

Sponsor: Suzhou Alphamab Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-09-02

Completion Date

2026-12-31

Last Updated

2024-12-24

Healthy Volunteers

No

Interventions

DRUG

KN057

KN057 will be administered subcutaneously once a week.