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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Administered once per day for 140 days.
Administered once per day for 140 days.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
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
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.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Time frame: At baseline, day 28, day 112 and day 140
Change from baseline in post-brondilator FEV1 after first drug administration
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Time frame: At baseline, day 28, day 112 and day 140
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