Healthy VolunteersPhase 1NCT03949530
A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
A Phase 1 study testing IDL-2965 Oral Capsule in people with Healthy Volunteers and Idiopathic Pulmonary Fibrosis, run by Indalo Therapeutics, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Idiopathic Pulmonary Fibrosis
- What is being tested?
- IDL-2965 Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2019to 29 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Healthy Volunteers, Idiopathic Pulmonary Fibrosis
- Being tested
- IDL-2965 Oral Capsule, Placebos
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDL-2965 Oral CapsuleDrug
Investigational drug
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| IDL-2965 Oral Capsule | Experimental | IDL-2965 oral capsule, single and multiple doses Receives: Drug: IDL-2965 Oral Capsule |
| Placebo Oral Capsule | Placebo comparator | Placebo oral capsule, single and multiple doses Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Safety
Measured: Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days
Secondary outcomes (1)
Pharmacokinetic (PK)
Area under the plasma concentration-time curve from time zero to 24 hours
Measured: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start16 Apr 2019
- Primary completion29 Mar 2020
- Study completion29 Mar 2020
Why it stopped: Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indalo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MRCS FFPM, Study director, Indalo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949530
- Sponsor's protocol ID
- Indalo (IDL)-2965-IPF-001
- Other IDs
- 2019-000173-23, 2019
- Status last verified
- Jul 2020
- First submitted
- 6 May 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03949530
- Acronym / sponsor ID
- Indalo (IDL)-2965-IPF-001
- Conditions
- Healthy Volunteers, Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indalo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 29 Mar 2020 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDL-2965 Oral Capsule | Experimental | Drug: IDL-2965 Oral CapsuleIDL-2965 oral capsule, single and multiple doses |
| Placebo Oral Capsule | Placebo comparator | Drug: PlacebosPlacebo oral capsule, single and multiple doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m2.
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDL-2965 Oral CapsuleInvestigational drug | Drug | IDL-2965 Oral Capsule |
| PlacebosPlacebo | Drug | Placebo Oral Capsule |
Primary outcome
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
1 secondary outcome
Pharmacokinetic (PK)
Time frame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days
Results and safety
The study was stopped early (reason given: Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Bush, MRCS FFPM study director
Indalo Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDL-2965 Oral Capsule in people with Healthy Volunteers and Idiopathic Pulmonary Fibrosis, run by Indalo Therapeutics, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.