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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: ZSP1603; Drug: Placebo

• Registration Number: NCT05119972
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-09
• Study Start: 2021-10-21
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
part1:ZSP1603 dose1	ZSP1603	-
part1:ZSP1603 dose2	ZSP1603	-
part1:ZSP1603 dose3	ZSP1603	-
Part2: ZSP1603 dose	ZSP1603	-
Part2: placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of ZSP1603	up to 15 Days	Pharmacokinetic analysis
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	up to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in FVC From Baseline at 12 weeks	up to 12 weeks	Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment.
Change in FVC%Pred from baseline at 12 weeks	up to12 weeks	Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.

Trial Locations

Locations (1)

Shanghai Lung Hospital; 🇨🇳 Shanghai, Shanghai, China