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Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of MG-ZG122 Humanized Monoclonal Antibody Injection in Adult Subjects With Moderate-to-Severe Asthma to Evaluate Efficacy and Safety

NCT07054034•Shanghai Mabgeek Biotech.Co.Ltd

View on ClinicalTrials.gov

Summary

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG-ZG122 Humanized Monoclonal Antibody Injection in Asthma Subjects, with Dosing Every 12 or 24 Weeks for 48 Weeks

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. Approximately 160 adult asthma subjects are scheduled to receive multiple subcutaneous injections (every 12 or 24 weeks for 48 weeks). The study is divided into a screening period (1 week), a run-in period (4 weeks), a treatment period (48 weeks), and a follow-up period (12 weeks).

Eligibility

Age

15 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must meet all of the following criteria to be enrolled in this study:
•Age: 18 to 75 years old (inclusive), male or female.
•Asthma Diagnosis:
•Diagnosed with asthma for at least 1 year, and current disease status meets the diagnostic criteria of the 2024 GINA Guidelines (Global Initiative for Asthma).
•Additionally:
•Has received moderate-to-high dose inhaled corticosteroids (ICS) for at least 2 consecutive months prior to screening.
•Pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at screening and baseline visits is ≤80% of predicted normal value.
•Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits.
•Has experienced ≥1 severe asthma exacerbation within the 12 months prior to screening.

Exclusion Criteria

•1， Known hypersensitivity to the investigational product or its excipients. 2，Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases potentially impairing lung function (e.g., idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchial dysplasia, etc.), as determined by the investigator., 3，Experienced a severe asthma exacerbation during the screening period or within 1 month prior to dosing., 4，Received systemic glucocorticoid therapy from 1 month prior to screening to prior to dosing (excluding topical, ophthalmic, or intranasal glucocorticoids).
•5，Had pulmonary or other site infections requiring intravenous antibiotics, antifungal, or antiviral medications within 1 month prior to dosing.
•6，Received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 3 months prior to dosing.
•7，Used traditional Chinese herbal medicines with bronchodilatory or anti-asthmatic effects (excluding topical preparations) within 1 month prior to dosing.
•8，Underwent major surgery within 8 weeks prior to screening or planned to undergo major surgery during the study period (including hospitalized surgery and day-case surgery).

Locations (1)

China-Japan Friendship Hospital, Beijing, China

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 11, 2025

Primary Completion Date

May 26, 2026

Completion Date

May 26, 2027

Last Updated

July 8, 2025

Enrollment

160

ESTIMATED participants

Conditions

Bronchial Asthma

Interventions

MG-ZG122 Humanized Monoclonal Antibody Injection

DRUG

Placebo

OTHER

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

NCT06624735

Bronchial Asthma

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COMPLETEDPHASE3

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

NCT06154304

Bronchial Asthma

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COMPLETED

the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

Inclusion Criteria

Exclusion Criteria

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.

Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital

Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital

The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population