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

Phase 1

Terminated

• Conditions: Healthy Volunteers; Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebos; Drug: IDL-2965 Oral Capsule

• Registration Number: NCT03949530
• Lead Sponsor: Indalo Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Primary Completion: 2020-03-29
• Study Completion: 2020-03-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Capsule	Placebos	Placebo oral capsule, single and multiple doses
IDL-2965 Oral Capsule	IDL-2965 Oral Capsule	IDL-2965 oral capsule, single and multiple doses

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Covance CRU; 🇬🇧 Leeds, United Kingdom