This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Shanghai Lung Hospital
Shanghai, Shanghai Municipality, China
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
Time frame: up to 16 weeks
Plasma concentrations of ZSP1603
Pharmacokinetic analysis
Time frame: up to 15 Days
Change in FVC From Baseline at 12 weeks
Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment.
Time frame: up to 12 weeks
Change in FVC%Pred from baseline at 12 weeks
Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.
Time frame: up to12 weeks
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