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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03949530
• Date of registration: 06/05/2019
• Prospective Registration: No
• Primary sponsor: Indalo Therapeutics, Inc.
• Public title: A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
• Scientific 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)
• Date of first enrolment: April 16, 2019
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03949530
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Jim Bush, MRCS FFPM
• Affiliation: Indalo Therapeutics, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: IDL-2965 Oral Capsule

Drug: Placebos

Primary Outcome(s)

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]

Secondary Outcome(s)

Pharmacokinetic (PK) [Time Frame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days]

Secondary ID(s)

2019-000173-23

Indalo (IDL)-2965-IPF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors