The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations

The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC).

Inclusion Criteria: 1. Sign the informed consent form (ICF); 2. Male or Female participants ages 40-80 (inclusive); 3. BMI ≥ 18.5 kg/m2 and ≤ 26 kg/m2, with male weight ≥50 kg and female weight ≥45 kg (inclusive); 4. Patients diagnosed with COPD according to 2024 GOLD consensus had a medical record or relevant documentation proving a history of COPD for ≥12 months at screening visit; 5. Current or former smokers with a smoking history of ≥10 pack-years; 6. Post-bronchodilator FEV1/ forced vital capacity \[FVC\] ratio \30% and ≤70%. 7. Sputum volume≥10ml/day at screening visit; 8. with a documented history: 1) Moderate-to-severe COPD patients with a stable SOC therapy prior to signing ICF, including LABA, LAMA, LABA/LAMA, LABA/LAMA/ICS (evaluated by investigator to confirm the treatment regimen complies with clinical practice); Continuous use with a stable dosage for ≥1 month prior to randomization; Medication compliance between 80% and 120% from signing ICF to randomization; 2) Acute exacerbation history of ≥2 moderate or ≥1 severe requiring hospitalization within 12 months prior to screening. 9. Medical Research Council (MRC) Dyspnea Scale grade ≥2. 10. COPD Assessment Test (CAT)≥10 Exclusion Criteria: 1. Have a primary diagnosis of asthma as determined by the investigator; 2. During screening period, WBC\