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

NCT05119972 | Completed Phase 1

• 1 other identifier: ZSP1603-20-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in FVC From Baseline at 12 weeks

  up to 12 weeks

• Change in FVC%Pred from baseline at 12 weeks

  up to12 weeks

Study Arms (5)

part1:ZSP1603 dose1

EXPERIMENTAL

Drug: ZSP1603

part1:ZSP1603 dose2

EXPERIMENTAL

Drug: ZSP1603

part1:ZSP1603 dose3

EXPERIMENTAL

Drug: ZSP1603

Part2: ZSP1603 dose

EXPERIMENTAL

Drug: ZSP1603

Part2: placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZSP1603 DRUG

ZSP1603 administered orally

Part2: ZSP1603 dose; part1:ZSP1603 dose1; part1:ZSP1603 dose2; part1:ZSP1603 dose3

Placebo DRUG

Placebo administered orally

Part2: placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Shanghai Lung Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 15, 2021
• Study Start: October 21, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CN (1)