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

• Status: Terminated
• Trial end date: 2020-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indalo Therapeutics, Inc.

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.