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A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT07256301 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-14

No results posted yet for this study

Summary

This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Conditions

  • PNH - Paroxysmal Nocturnal Hemoglobinuria

Interventions

BIOLOGICAL

EA5

All treatments were given as IV infusions.

Sponsors & Collaborators

  • Shanghai Lanyi Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengkui Zhang, Dr. · The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)

  • Hongyan Tong, Dr. · The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2026-08-31
Completion
2026-10-30

Countries

  • China

Study Locations

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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 NCT07256301 on ClinicalTrials.gov