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

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

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 Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: Placebo; Drug: ZSP1603

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Huiping Li, Professor; Phone Number: 021-65115006; Email: liw2013@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Lung Hospital
      • Contact: Huiping Li, Professor; Phone Number: 021-65115006; Email: liw2013@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: part1:ZSP1603 dose1	Drug: ZSP1603; ZSP1603 administered orally
Experimental: part1:ZSP1603 dose2	Drug: ZSP1603; ZSP1603 administered orally
Experimental: part1:ZSP1603 dose3	Drug: ZSP1603; ZSP1603 administered orally
Experimental: Part2: ZSP1603 dose	Drug: ZSP1603; ZSP1603 administered orally
Placebo Comparator: Part2: placebo	Drug: Placebo; Placebo administered orally

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

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Estimated): December 21, 2023
• Study Completion (Estimated): December 21, 2023

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ZSP1603-20-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No