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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2023-12-21

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded

ZSP1603 administered orally

Intervention Type DRUG

Placebo

Placebo administered orally

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No