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)

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Pulmonary Fibrosis; Healthy Volunteers
• Intervention / Treatment: Drug: Placebos; Drug: IDL-2965 Oral Capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Covance CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indalo Therapeutics, Inc.
• Investigators: Study Director: Jim Bush, MRCS FFPM, Indalo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): March 29, 2020
• Study Completion (Actual): March 29, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: Indalo (IDL)-2965-IPF-001; 2019-000173-23 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No