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KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

NCT05421429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-30

No results posted yet for this study

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

Interventions

BIOLOGICAL

KN057 doseⅠ

KN057 subcutaneous (SC) injection

BIOLOGICAL

KN057 dose Ⅱ

KN057 SC injection

BIOLOGICAL

KN057 dose Ⅲ

KN057 SC injection

Sponsors & Collaborators

  • Suzhou Alphamab Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Renchi Yang, Doctor · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

  • Shujie Wang, Doctor · Peking Union Medical College Hospital

  • Hu Zhou, Doctor · Henan Cancer Hospital（The Affiliated Cancer Hospital Of ZhengZhou University)

  • Ziqiang Yu, Doctor · The First Affiliated Hospital of Soochow University

  • Changcheng Zheng, Doctor · The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  • Jing Sun, Doctor · Nanfang Hospital, Southern Medical University

  • Xielan Zhao, Doctor · Xiangya Hospital of Central South University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421429 on ClinicalTrials.gov