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

Laborértékek

• During screening period, WBC\<the lower limit of normal range, or absolute neutrophil count\<the lower limit of normal range;

Egyéb

• Have a primary diagnosis of asthma as determined by the investigator;
• During screening period, blood eosinophils ≥300 cells/microliter;
• Pregnant and lactating females

• Sign the informed consent form (ICF);
• Male or Female participants ages 40-80 (inclusive);
• BMI ≥ 18.5 kg/m2 and ≤ 26 kg/m2, with male weight ≥50 kg and female weight ≥45 kg (inclusive);
• 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;
• Current or former smokers with a smoking history of ≥10 pack-years;
• Post-bronchodilator FEV1/ forced vital capacity \[FVC\] ratio \<0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%.
• Sputum volume≥10ml/day at screening visit;
• 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.
• Medical Research Council (MRC) Dyspnea Scale grade ≥2.
• COPD Assessment Test (CAT)≥10