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

• ClinicalTrials.gov Identifier: NCT03949530
• Recruitment Status: Terminated
• First Posted: May 14, 2019
• Last Update Posted: August 4, 2020
• Sponsor: Indalo Therapeutics, Inc.
• Information provided by (Responsible Party): Indalo Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers; Idiopathic Pulmonary Fibrosis	Drug: IDL-2965 Oral Capsule; Drug: Placebos	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: 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)
• Actual Study Start Date: April 16, 2019
• Actual Primary Completion Date: March 29, 2020
• Actual Study Completion Date: March 29, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 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 :

1. Pharmacokinetic (PK) [ Time Frame: 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 Outcome Measures:

1. Exploratory Pharmacodynamic (PD) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United Kingdom

Covance CRU

Leeds, United Kingdom

Sponsors and Collaborators

Indalo Therapeutics, Inc.

Investigators

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

More Information

• Responsible Party: Indalo Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03949530
• Other Study ID Numbers: Indalo (IDL)-2965-IPF-001; 2019-000173-23 ( EudraCT Number )
• First Posted: May 14, 2019
• Last Update Posted: August 4, 2020
• Last Verified: July 2020

• 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

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases