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Not yet recruiting NCT07035652

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

Phase I Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XH-S004 20 mg, 40 mg or 60 mg, Placebo.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

This study is a multicenter, double-blind, placebo-controlled, up-titration study conducted in china, aimed at evaluating the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of XH-S004 administered once daily for 140 days in COPD patients.

This study plans to enroll 81 COPD patients. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 2 groups in 2:1 ratio (XH-S004 group: 54 participants and placebo group: 27 participants). Participants in XH-S004 group will receive XH-S004 20 mg for 28 days in treatment period 1, then up-titrated to XH-S004 40 mg for 84 days in treatment period 2, finally continue with XH-S004 60 mg for 28 days in treamtment period 3. Participants in placebo group will receive matching placebo from day 1 to day 140 (140 days in total).

Interventions

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

Primary outcome measures

  • Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time frame: From randomisation to study completion, up to 168 days]
Secondary outcome measures (7)
  • Time to reach maximum plasma concentration (Tmax) [Time frame: From randomisation to study completion, up to 168 days]
  • Maximum measured concentration (Cmax) of XH-S004 [Time frame: From randomisation to study completion, up to 168 days]
  • Maximum measured concentration of XH-S004 at steady state (Cmax,ss) [Time frame: From randomisation to study completion, up to 168 days]
  • Area Under the Plasma Concentration-time Curve (AUC) of XH-S004 [Time frame: From randomisation to study completion, up to 168 days]
  • Change From Baseline in Blood Concentration of Active Neutrophil Elastase (NE) [Time frame: From randomisation to study completion, up to 168 days]
  • Change from baseline in pre-brondilator FEV1 after first drug administration. [Time frame: At baseline, day 28, day 112 and day 140]
  • Change from baseline in post-brondilator FEV1 after first drug administration [Time frame: At baseline, day 28, day 112 and day 140]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07035652 · XH-S004-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗