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

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ZSP1603
Placebo
Sponsored by
Guangdong Raynovent Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Shanghai Lung HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

part1:ZSP1603 dose1

part1:ZSP1603 dose2

part1:ZSP1603 dose3

Part2: ZSP1603 dose

Part2: placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
Plasma concentrations of ZSP1603
Pharmacokinetic analysis

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2021
Last Updated
July 16, 2023
Sponsor
Guangdong Raynovent Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05119972
Brief Title
Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Raynovent Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis (IPF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
part1:ZSP1603 dose1
Arm Type
Experimental
Arm Title
part1:ZSP1603 dose2
Arm Type
Experimental
Arm Title
part1:ZSP1603 dose3
Arm Type
Experimental
Arm Title
Part2: ZSP1603 dose
Arm Type
Experimental
Arm Title
Part2: placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZSP1603
Intervention Description
ZSP1603 administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
up to 16 weeks
Title
Plasma concentrations of ZSP1603
Description
Pharmacokinetic analysis
Time Frame
up to 15 Days
Secondary Outcome Measure Information:
Title
Change in FVC From Baseline at 12 weeks
Description
Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment.
Time Frame
up to 12 weeks
Title
Change in FVC%Pred from baseline at 12 weeks
Description
Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.
Time Frame
up to12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiping Li, Professor
Phone
021-65115006
Email
liw2013@126.com
Facility Information:
Facility Name
Shanghai Lung Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiping Li, Professor
Phone
021-65115006
Email
liw2013@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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