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A Phase I, Dose Escalation, Open-label, Multicenter Study of EA5 Injection in Adults With APS and Recurrent Thrombosis

NCT07632976 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-06-08

No results posted yet for this study

Summary

This is a Phase I, open-label, dose escalation, multicenter study to evaluate the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of EA5 injection in adult participants with Antiphospholipid Syndrome (APS) and recurrent thrombosis who are receiving standard-of-care antithrombotic therapy. Approximately 12 participants will be enrolled. The whole study treatment cycle was 24 weeks. Administration of low-dose EA5: First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Administration of high-dose EA5: First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of preliminary efficacy, immunogenicity, PK, PD (complement inhibition), and APS-related biomarker changes.

Conditions

Interventions

BIOLOGICAL

EA5

Administer the loading dose regimen intravenously, then maintain administration subcutaneously

BIOLOGICAL

EA5

Administer the loading dose regimen intravenously, then maintain administration subcutaneously

Sponsors & Collaborators

  • Shanghai Lanyi Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07632976 on ClinicalTrials.gov