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

Indalo Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers; Idiopathic Pulmonary Fibrosis

Treatments: Drug: Placebos; Drug: IDL-2965 Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03949530

2019-000173-23 (EudraCT Number)

Indalo (IDL)-2965-IPF-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

IDL-2965 Oral Capsule

Experimental group

Description:

IDL-2965 oral capsule, single and multiple doses

Treatment:

Drug: IDL-2965 Oral Capsule

Placebo Oral Capsule

Placebo Comparator group

Description:

Placebo oral capsule, single and multiple doses

Treatment:

Drug: Placebos