This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Take twice daily, about 12 hours apart, after meals, for 12 weeks.
Take twice daily, about 12 hours apart, after meals, for 12 weeks.
Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Time frame: Week 12
Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Time frame: Week 2,4,8
Change in FVCpp from baseline
Time frame: Week 12
Proportion of participants with an absolute decrease in FVCpp >10% from baseline
Time frame: Week 12
Proportion of participants with no decrease in FVCpp from baseline
Time frame: Week 12
Adjusted change in DLCOpp from baseline
Time frame: Week 12
Change from baseline in L-PF scale score
The L-PF questionnaire is used to assess patients' symptoms. It consists of 21 items covering two main domains: the Symptom Module and the Impact Module. Higher scores indicate more severe symptoms and poorer quality of life.
Time frame: Week 12
Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline
The Visual Analogue Scale (VAS) is a commonly used clinical tool for assessing the intensity of subjective symptoms. It typically consists of a 0 - 10 cm line segment, where 0 indicates no symptoms and 10 indicates the most severe symptoms.
Time frame: Week 12
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Incidence and severity of adverse events
Time frame: Week 13
Changes in C-SSRS over time during the trial
The Columbia Suicide Severity Rating Scale (C-SSRS) is an internationally recognized standardized tool for suicide risk assessment. It systematically evaluates suicidal ideation , suicidal behavior and self-injurious behavior. Suicidal ideation is graded in severity on a 1 -5 scale, with higher scores indicating stronger suicidal ideation.
Time frame: Week 13
Plasma concentrations of sparsely sampled participants pre-dose and 2 hours post-dose on Day 14 and Day 84
Time frame: Week 2,12
PK parameters after the first dose in intensively sampled participants: Cmax.
Time frame: Day 1
PK parameters after the first dose in intensively sampled participants: AUC0-12.
Time frame: Day 1
PK parameters after the first dose in intensively sampled participants: Tmax.
Time frame: Day 1
PK parameters after multiple doses in intensively sampled participants: Ctau,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmax,ss
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmin,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: AUC0-tau,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Tmax,ss.
Time frame: Week 1,2
Changes in blood biomarkers from baseline.
Time frame: Week 4,8,12