Overview

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.