IPFNCT07929948

A Phase Ⅱa Study of ND-003 Tablets in Patients With Idiopathic Pulmonary Fibrosis

StatusEnrolling by Invitation

PhasePhase 2

SponsorShenzhen NewDEL Biotech, Co., Ltd

Primary completionJun 30, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Nov 4, 2026 Study First Submitted

Endpoints

Primary

Proportion of participants with a ≥10% decline in forced vital capacity (FVC) from baseline.

Timeframe: Day 1 and Week 24

Secondary (11)

Absolute change from baseline in percent predicted forced vital capacity (%FVC)

Change from baseline in absolute forced vital capacity (FVC)

Change from baseline in hemoglobin-corrected percent predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp)

Change from baseline in serum KL-6 levels

Change from baseline in the quantitative extent of pulmonary fibrosis assessed by high-resolution computed tomography (HRCT)

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Progression-free survival (PFS)

Proportion of participants experiencing an acute exacerbation of IPF

IPF-related mortality and all-cause mortality

Change from baseline in the A Tool to Assess Quality of Life in IPF (ATAQ-IPF) score

Change From Baseline in Six-Minute Walk Distance (6MWD) Assessed by the Six-Minute Walk Test (6MWT)

Adverse Events (AE)

Arms and interventions

100 mg dose groupExperimental

Under fasting conditions (it is recommended that participants refrain from food, but not water, for 2 hours before and 1 hour after dosing), ND-003 tablets 100 mg (1 tablet) should be administered orally once daily with warm water.

200 mg dose groupExperimental

Under fasting conditions (it is recommended that participants refrain from food, but not water, for 2 hours before and 1 hour after dosing), ND-003 tablets 200 mg (2 tablets) should be administered orally once daily with warm water.

Drugs: ND-003 Tablets

Sites

1 site in 1 country

Guangzhou Chest HospitalGuangzhou, China

About this trial

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial lung disease that predominantly affects middle-aged and older adults. Progressive replacement of normal lung parenchyma by extracellular matrix and destruction of the alveolar architecture lead to reduced lung compliance and impaired gas exchange. Clinically, IPF is characterized by progressively worsening dyspnea, restrictive ventilatory impairment, impaired gas exchange, hypoxemia, and, in advanced cases, respiratory failure. Current pharmacological treatment of IPF is primarily based on antifibrotic therapy. Pirfenidone and nintedanib were the first two antifibrotic agents approved for IPF and have been shown to slow the decline in forced vital capacity (FVC) through different mechanisms of action. Pirfenidone is an oral small-molecule agent with antifibrotic, anti-inflammatory, and antioxidant properties. Although its mechanism of action has not been fully elucidated, it is thought to involve inhibition of transforming growth factor-beta (TGF-β)-related signaling and suppression of fibroblast proliferation. Nintedanib is a multitarget tyrosine kinase inhibitor that inhibits several receptors involved in fibrotic pathways, including vascular endothelial growth factor receptors (VEGFRs), fibroblast growth factor receptors (FGFRs), and platelet-derived growth factor receptors (PDGFRs). More recently, nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor with anti-inflammatory and antifibrotic activity, has also been developed for the treatment of IPF. Despite these therapeutic advances, currently available treatments mainly slow disease progression and do not reverse established pulmonary fibrosis or cure IPF. In addition, treatment may be limited by adverse reactions and tolerability issues. Common adverse reactions associated with pirfenidone include gastrointestinal symptoms, photosensitivity reactions, and rash, while diarrhea is a frequent adverse reaction associated with nintedanib. Therefore, there remains an unmet medical need for novel therapies with improved efficacy and an acceptable safety and tolerability profile. ND-003, formerly known as ND003, is a novel small-molecule compound jointly developed by Shenzhen Xinyue Biotechnology Co., Ltd. and Shenzhen Small Molecule Innovative Drug Center Co., Ltd. for the treatment of pulmonary fibrosis. ND-003 is a kinase inhibitor targeting discoidin domain receptor 1 (DDR1), colony-stimulating factor 1 receptor (CSF1R), and platelet-derived growth factor receptor beta (PDGFR-β). By selectively interacting with these targets and modulating signaling pathways involved in fibrotic processes, ND-003 is intended to inhibit or delay the progression of tissue fibrosis. The primary objective of this study is to evaluate the preliminary efficacy of ND-003 tablets in patients with idiopathic pulmonary fibrosis and to provide scientific evidence to support dose selection for subsequent clinical development. The study will also evaluate the safety and tolerability of ND-003 tablets in patients with IPF.

Trial details

Enrollment: 10 participants (estimated)
Started: Aug 18, 2026
Study completion: Dec 31, 2028 (estimated)
Eligibility: 40 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
Collaborators: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
Official title: A Single-Center, Randomized, Open-Label, Phase IIa Proof-of-Concept Clinical Trial to Evaluate the Efficacy and Safety of ND-003 Tablets in Chinese Patients With Idiopathic Pulmonary Fibrosis
First posted: Nov 10, 2026
Registry updated: Nov 10, 2026
Last verified: Nov 2026

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