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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorS-INFINITY Pharmaceuticals Co., Ltd

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

Treatment groups

81 Participants
are divided into 2 treatment groups