Evaluating MG-K10 for treating asthma in adults
Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects
This study tests if a new treatment called MG-K10 can help adults with moderate to severe asthma breathe better and feel safer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Mabgeek Biotech.Co.Ltd Government |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05382910 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of MG-K10, a humanized monoclonal antibody, in adult patients with asthma. It consists of two phases: Phase Ib focuses on assessing the safety and tolerability of the treatment, while Phase II aims to determine its preliminary efficacy in adults suffering from moderate to severe asthma. Participants will receive either the MG-K10 injection or a placebo to compare outcomes. The study is conducted in accordance with the GINA guidelines for asthma management.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with asthma for at least one year, experiencing frequent severe asthma attacks.
Not a fit: Patients with chronic obstructive pulmonary disease (COPD) or other significant lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for adults with moderate to severe asthma.
How similar studies have performed: Other studies involving monoclonal antibodies for asthma treatment have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year; * 1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value; * Must have experienced at least one severe acute asthma attack within 12 months outbreak event. * Positive bronchodilator test * Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment Exclusion Criteria: * Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function * Subjects with malignant tumor within 5 years * Received biologics with the same therapeutic purpose within 6 months prior to screening, * Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Nanshan Zhong, Medical PhD — The First Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Xiaofeng Cai, bachelor
- Email: xiaofeng.cai@mabgeek.com
- Phone: 02151371305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.