DEVELOPMENT OF INNOVATIVE TARGETED LIPOSOMAL FORMULATIONS... | NCT07571291

Studies
DEVELOPMENT OF INNOVATIVE TARGETED LIPOSOMAL FORMULATIONS FOR THE TREATMENT OF INFLAMMATORY DRIVEN PULMONARY FIBROSIS

NCT07571291

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Active, not recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Pulmonary Fibrosis

Interventions

liposomes as drug delivery system

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 29, 2026

First Submission Date that Met QC Criteria

Apr 29, 2026

First Posted Date

May 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veronica Codullo, MD PhD, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to develop an innovative nano-platform for the treatment of lung fibrogenic disorders (LFD). The approach involves local delivery by inhalation of drug-loaded liposomes, coated with hyaluronic acid (HA) to directly target CD44+ pathogenic cells. We aim to expand and develop the formulation "XHALIP¿ (patent pending) by the following steps: 1) Characterization of safety and bioavailability in healthy and lung fibrogenic disorders (LFD) mice; 2) Evaluation of the pharmacokinetics and uptake by human LFD fibroblasts and macrophages and on healthy/LFD mice; 3) testing of antifibrotic/-inflammatory activities of the most promising XHALIP on mouse LFD models and translational studies on lung cells/tissues from LFD patients AIM 1: XHALIP characterization and bio-nano interaction AIM 2: Organ and cell lung Targeting AIM 3: Efficacy assessment in lung fibrosis models

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liposomes as drug delivery system	Device	TEst in vitro ability of specific liposomes to deliver drugs to fibroblasts and macrophages from pulmonary fibrosis patients

Measure	Description	Time Frame
liposome characterization and bio-nano interaction		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of pulmonary fibrotic conditions (idiopathic, Connective Tissue Disease Associated)

Exclusion Criteria:

Unwilling to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients of the Rheumatology and Pneumology unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology unit IRCCS Policlinico San Matteo Pavia		Pavia		27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

A patent is pending for the liposomes in study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011658	Pulmonary Fibrosis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016503	Drug Delivery Systems

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided