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A Study of HBM9161 in NMOSD Patients

NCT04227470 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-01-25

No results posted yet for this study

Summary

Primary Objectives:To investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China

Conditions

  • NMO Spectrum Disorder

Interventions

DRUG

HBM9161 Injection

Subcutaneous injection; Weekly administered for a period of 4 weeks. All subjects are treated with the testing drug, add on intravenous methylprednisolone (ivMP) with gradually reduce the dose then to oral prednisone. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.

Sponsors & Collaborators

  • Harbour BioMed (Guangzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Qiu · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-12-03
Completion
2021-12-24

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 NCT04227470 on ClinicalTrials.gov