EU-IPFF committed to promoting research in Pulmonary Fibrosis

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05119972
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangdong Raynovent Biotech Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis (IPF)

Arms & Interventions

Arms

Experimental: part1:ZSP1603 dose1

Experimental: part1:ZSP1603 dose2

Experimental: part1:ZSP1603 dose3

Experimental: Part2: ZSP1603 dose

Placebo Comparator: Part2: placebo

Interventions

Drug: - ZSP1603

ZSP1603 administered orally

Drug: - Placebo

Placebo administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.