Clincosm LogoSign in Get a demo

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

Sponsor
Guangdong Raynovent Biotech Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05119972
Collaborator
(none)
36
Enrollment
1
Location
5
Arms
12
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
Oct 21, 2022
Anticipated Study Completion Date :
Oct 21, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [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 [up to 15 Days]

    Pharmacokinetic analysis

Secondary Outcome Measures

  1. Change in FVC From Baseline at 12 weeks [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 [up to12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Lung Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Guangdong Raynovent Biotech Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangdong Raynovent Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT05119972
Other Study ID Numbers:
  • ZSP1603-20-02
First Posted:
Nov 15, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis

Study Results

No Results Posted as of Nov 15, 2021