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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Healthy Volunteers, Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: IDL-2965 Oral Capsule
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDL-2965 Oral Capsule<br>IDL-2965 oral capsule, single and multiple doses | Drug: IDL-2965 Oral Capsule<br>* Investigational drug<br>|
| Placebo Comparator: Placebo Oral Capsule<br>Placebo oral capsule, single and multiple doses | Drug: Placebos<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Safety | Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days | 

Secondary Outcome Measures

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