NCT05119972CompletedPhase 1/2
Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）
A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 9 Oct 2021
- Start date
- 21 Oct 2021
- Primary completion date
- 21 Dec 2023
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05119972
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 15
- From 21 Oct 2021 to the primary completion date, 21 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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;
Other illness
- Poorly controlled cardiovascular and cerebrovascular diseases;
Other
- FEV1/FVC\< 0.7;
- PaO2 in resting state without oxygen inhalation \< 50mmHg;
Who the study is looking for
- 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;
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Lung Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.