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Completed

NCT Number: NCT05119972

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Lung Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ZSP1603

Drug

ZSP1603 administered orally

Placebo

Drug

Placebo administered orally

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  2. Plasma concentrations of ZSP1603

    Time frame: up to 15 Days

    Pharmacokinetic analysis

Secondary outcomes

  1. Change in FVC From Baseline at 12 weeks

    Time frame: up to 12 weeks

    Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment.

  2. Change in FVC%Pred from baseline at 12 weeks

    Time frame: up to12 weeks

    Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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