About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- XH-S004 20 mg, 40 mg or 60 mg
- Placebo