A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis

IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03949530

Enrollment

Registered

2019-05-14

Start date

2019-04-16

Completion date

2020-03-29

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Idiopathic Pulmonary Fibrosis

Brief summary

The purpose of this study is to test the safety and tolerability of the drug candidate IDL-2965 and to see how it is absorbed, processed, and removed by the body.

Detailed description

IDL-2965 is an oral integrin antagonist antifibrotic being studied as a potential treatment for IPF and Nonalcoholic Steatohepatitis (NASH). This double-blind, randomized, placebo-controlled, single and multiple oral dose study will be conducted in 3 parts. Part A will comprise a single-dose, sequential-group design in healthy subjects, incorporating a food-effect evaluation. Part B will consist of a multiple-dose, sequential-group design in healthy subjects. Part C will be a multiple-dose, sequential-group design in subjects with IPF.

Interventions

DRUGIDL-2965 Oral Capsule

Investigational drug

DRUGPlacebos

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy subjects: • Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m2. IPF subjects: * Male and female subjects over 40 years of age. * Diagnosis of idiopathic pulmonary fibrosis * Idiopathic pulmonary fibrosis has been stable for at least 3 months.

Exclusion criteria

Healthy subjects and IPF subjects: * Significant history or clinical manifestation of any disease/disorder, other than IPF. * History of significant hypersensitivity, intolerance, or allergy to any drug compound * Poor peripheral venous access * Use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes. * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs IPF subjects: • Pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.

Design outcomes

Primary

Measure	Time frame	Description
Incidence and severity of treatment emergent Adverse Events (AEs), AEs leading to discontinuation from Investigational Medicinal Product (IMP) or the study, serious adverse events (SAEs), and deaths.	Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days	Safety

Secondary

Measure	Time frame	Description
Pharmacokinetic (PK)	SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days	Area under the plasma concentration-time curve from time zero to 24 hours

Other

Measure	Time frame	Description
Exploratory Pharmacodynamic (PD)	SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 28 Days	Change from baseline in phosphorylated small mothers against decapentaplegic (pSMAD) from bronchoalveolar lavage fluid cells

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026