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).
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;
Have a primary diagnosis of asthma as determined by the investigator;
During screening period, WBC<the lower limit of normal range, or absolute neutrophil count<the lower limit of normal range;
During screening period, blood eosinophils ≥300 cells/microliter;
Pregnant and lactating females
Parallel
XH-S004 20 mg, 40 mg or 60 mg
Other interventionAdministered once per day for 140 days.
Placebo
Other interventionAdministered once per day for 140 days.
Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time to reach maximum plasma concentration (Tmax)
Maximum measured concentration (Cmax) of XH-S004
Maximum measured concentration of XH-S004 at steady state (Cmax,ss)
Area Under the Plasma Concentration-time Curve (AUC) of XH-S004
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