Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
-----------------
* Drug: ZSP1603
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management; Dlco (corrected for Hb): 30%-79% predicted of normal; FVC>= 50% predicted of normal; Exclusion Criteria: FEV1/FVC< 0.7; PaO2 in resting state without oxygen inhalation < 50mmHg; Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator; Poorly controlled cardiovascular and cerebrovascular diseases; Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone > 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment;

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: part1:ZSP1603 dose1<br> | Drug: ZSP1603<br>* ZSP1603 administered orally<br>|
| Experimental: part1:ZSP1603 dose2<br> | Drug: ZSP1603<br>* ZSP1603 administered orally<br>|
| Experimental: part1:ZSP1603 dose3<br> | Drug: ZSP1603<br>* ZSP1603 administered orally<br>|
| Experimental: Part2: ZSP1603 dose<br> | Drug: ZSP1603<br>* ZSP1603 administered orally<br>|
| Placebo Comparator: Part2: placebo<br> | Drug: Placebo<br>* Placebo administered orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 16 weeks | 
| Plasma concentrations of ZSP1603 | Pharmacokinetic analysis | up to 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FVC From Baseline at 12 weeks | Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment. | 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. | up to12 weeks |