A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

Inclusion Criteria

• •1. Age at least 40 years old at the time of signing the informed consent form, both gender;
• •2. Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and/or with chronic productive cough at least 12 months prior to screening;
• •3. Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio\<70% after albuterol use, and FEV1 after albuterol use\>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;
• •4. Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).
• •5. At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).
• •6. Subjects voluntarily participate in this clinical trial and sign the informed consent form.