A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
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ClinicalTrials.gov Identifier: NCT03949530 |
Recruitment Status :
Terminated
(Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data)
First Posted : May 14, 2019
Last Update Posted : August 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers Idiopathic Pulmonary Fibrosis | Drug: IDL-2965 Oral Capsule Drug: Placebos | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: IDL-2965 Oral Capsule
IDL-2965 oral capsule, single and multiple doses
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Drug: IDL-2965 Oral Capsule
Investigational drug |
Placebo Comparator: Placebo Oral Capsule
Placebo oral capsule, single and multiple doses
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Drug: Placebos
Placebo |
- 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
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949530
United Kingdom | |
Covance CRU | |
Leeds, United Kingdom |
Study Director: | Jim Bush, MRCS FFPM | Indalo Therapeutics, Inc. |
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 Key Record Dates |
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 |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis |
Pathologic Processes Lung Diseases Respiratory Tract Diseases |