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

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119972
• Other study ID #: ZSP1603-20-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 21, 2021
• Est. completion date: December 21, 2023

Study information

• Verified date: July 2023
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: Huiping Li, Professor
• Phone: 021-65115006
• Email: liw2013[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• ZSP1603
ZSP1603 administered orally
• Placebo
Placebo administered orally

Locations

Country	Name	City	State
China	Shanghai Lung Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Plasma concentrations of ZSP1603	Pharmacokinetic analysis	up to 15 Days
Secondary	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
Secondary	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