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Clinical Trials in China / NCT07035652
Starting soon Phase 1

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

NCT07035652 · tracked via the Priya Life Science China tracker
Sponsor
S-INFINITY Pharmaceuticals Co., Ltd
Phase
Phase 1
Started
2025-07-15
Last updated
2025-06-25

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

XH-S004 20 mg, 40 mg or 60 mgPlacebo

XH-S004 20 mg, 40 mg or 60 mg: Administered once per day for 140 days.

Placebo: Administered once per day for 140 days.

Study summary

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

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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 \<0.70 and post-bronchodilator FEV1 % predicted \>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\<the lower limit of normal range, or absolute neutrophil count\<the lower limit of normal range; 3. During screening period, blood eosinophils ≥300 cells/microliter; 4. Pregnant and lactating females

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality

More S-INFINITY Pharmaceuticals Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035652 on ClinicalTrials.gov ↗ ← All trials in China