Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma

Inclusion criteria:

1. Age between 12~75 years old (including the critical value), male and female, weight ≥ 30kg;

2. Diagnosed with asthma for at least 1 year and current disease status that meets thediagnostic criteria of the 2024 GINA guidelines, and:

1. Subjects have received moderate-high dose ICS therapy for at least 2 consecutivemonths before screening (see Appendix 5 for details, fluticasone propionate ≥250 μgtwice a day, or an equivalent dose of ICS, no more than 2000 μg/day or equivalentdose of fluticasone propionate) combined with 1 control drug (such as LABA, LTRA,LAMA or extended-release theophylline), and maintained a stable treatment regimenand dose therapy for ≥ 1 month before baseline. Subjects using the third controldrug can also participate in the study, but the subjects must also use the thirdcontrol drug for at least 2 consecutive months before screening, and maintain astable treatment regimen and dose treatment ≥ 1 month before baseline; 2) 1-secondforced expiratory volume (FEV1) before bronchodilator use at the screening andbaseline visits, measured ≤ 80% of the normal predicted value for adults and 90% ofthe normal predicted value ≤ for adolescents; 3) Asthma Control Questionnaire-5 (ACQ-5) score ≥ 1.5 points at the screening and baseline visits; 4) Must haveexperienced ≥ 1 acute exacerbation event within 12 months prior to screening: needto receive 1 ≥ systemic glucocorticoids (oral or intravenous) treatment due toasthma exacerbation or need hospitalization/emergency treatment; 5）A positivebronchodilator test (a ≥12% increase in FEV1 after inhalation of bronchodilators andan absolute increase in FEV1 ≥200 mL) will be acceptable for bronchodilator testresults within 24 months prior to screening； Positive bronchodilator test (afterinhaling a bronchodilator, the forced expiratory volume in one second (FEV1)increases by ≥12%, and the absolute value of FEV1 increases by ≥200 mL). The resultsof the bronchodilator test conducted within 24 months before screening areacceptable.

3.The subjects (including adolescents aged 12 years old ≤ age < 18 years old) agree that they themselves and their partners will adopt effective contraceptive measures from the signing of the Informed Consent Form (ICF) until 6 months after the last administration of the drug.

4.The subject and his/her guardian (applicable to adolescents aged 12 years old ≤ age < 18 years old) are able to understand the procedures and methods of this study, willing to sign the Informed Consent Form, strictly abide by the clinical research protocol to complete the study, and capable of independently completing the study-related questionnaires.

Exclusion criteria:

1. Subjects with known hypersensitivity to the investigational product or itsexcipients;

2. Subjects who, within 1 month prior to screening and drug administration, haverequired systemic glucocorticoid therapy (oral or intravenous) for asthmaexacerbation at least once, or have required hospitalization/emergency treatment dueto asthma exacerbation.

3. Subjects who, within 1 month prior to screening and drug administration, haverequired at least one course of systemic glucocorticoid therapy (oral or intravenousadministration) for asthma exacerbation, or have required hospitalization oremergency treatment due to asthma exacerbation.

4. Subjects who have received systemic glucocorticoid therapy from 1 month beforescreening until drug administration (excluding those with topical, ophthalmic, orintranasal glucocorticoid use)

5. Subjects who have received intravenous immunoglobulin (IVIG) therapy orallergen-specific immunotherapy (SIT) within 1 month prior to drug administration.

6. Subjects who have undergone major surgery within 8 weeks prior to screening havescheduled major surgery during the study period, including inpatient and day-caseoutpatient procedures.

7. Subjects with a history of substance abuse or illicit drug use.

8. Subjects with any other conditions that, in the investigator's judgment, maycompromise subject safety or trial integrity.