Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT06683612
PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF
A Phase 1 study testing PIPE-791 in people with Idiopathic Pulmonary Fibrosis (IPF) and Idiopathic Pulmonary Fibrosis, run by Contineum Therapeutics at 1 site in United Kingdom.
Trial summary
This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Pulmonary Fibrosis, Multiple Sclerosis
- What is being tested?
- PIPE-791
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2024to 12 Jun 2025
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria
- All parts: male volunteers or female volunteers of non-childbearing potential; agree to follow the contraception requirements of the trial, and able to give fully informed written consent.
- Part A: normotensive volunteers, deemed healthy on the basis of a clinical history, medical examinations, ECG, vital signs, and laboratory tests of blood and urine.
- Part B: volunteers with a diagnosis of PPMS or SPMS by a neurologist, according to the 2017 Revised McDonald Criteria.
- Part C: volunteers with a diagnosis of IPF by a pulmonologist, according to the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline, within 7 years before screening.
Main Exclusion Criteria
- Positive tests for hepatitis B and C, human immunodeficiency virus (HIV)
- Severe adverse reaction to any drug; sensitivity to trial medication
- Drug or alcohol abuse
- Smoking or use of tobacco or nicotine-containing products from 7 days before screening, until the final visit
- Use of a prescription medicine (except hormone replacement therapy [HRT] in women, and medications for participants with PrMS and IPF at the discretion of the investigator), or any substance known to interact with cytochrome p450 (CYP)3A enzymes (including St. John's wort and foodstuffs such as grapefruit juice) during the 28 days before the first dose of PIPE-791
- Use of any other over-the-counter medicine, with the exception of acetaminophen (paracetamol) during the 7 days before the first dose of PIPE-791, or received vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), during the 7 days before screening
- Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the 3 months before the baseline PET scan
- Vital signs or ECGs outside the acceptable range at screening
- Clinically relevant abnormal findings at the screening assessments, including C-SSRS and MRI (Parts A [brain PET imaging arm] and B only)
- Acute or chronic illness (except PrMS and IPF in Parts B and C, respectively)
- Clinically relevant abnormal medical history or concurrent medical condition
- Possibility that volunteer will not cooperate
- Contraindications to MRI (Parts A [brain PET imaging arm] and B only), computed tomography (CT), PET, or arterial cannulation procedures
- Significant exposure to research-related radiation or other radiation exposure (exceeding 10 mSv when added to exposure from this study) within the previous 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis
This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.
Participants will:
- Take a single dose of the study drug
- Give many samples of blood and urine
- Have multiple PET scans
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Pulmonary Fibrosis, Multiple Sclerosis, Multiple Sclerosis, MS, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Progressive
- Being tested
- PIPE-791
- Keywords
- remyelination, MS, multiple sclerosis, PrMS, PPMS, SPMS, primary progressive MS, primary progressive multiple sclerosis, secondary progressive multiple sclerosis, secondary progressive MS, LPA1, PMS, idiopathic pulmonary fibrosis, IPF, neuroinflammation, PIPE-791, demyelinating diseases, autoimmune diseases, pathologic processes, demyelinating autoimmune diseases, CNS
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Neuroinflammatory Diseases, Demyelinating Diseases, Autoimmune Diseases, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPE-791Drug
Subjects will receive a single oral dose of PIPE-791.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers, brain PET imaging | Experimental | Not described Receives: Drug: PIPE-791 |
| Healthy volunteers, lung PET imaging | Experimental | Not described Receives: Drug: PIPE-791 |
| Volunteers with PrMS | Experimental | Not described Receives: Drug: PIPE-791 |
| Volunteers with IPF | Experimental | Not described Receives: Drug: PIPE-791 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.
Measured: Baseline to up to 28 days post-dose
LPA1 occupancy as determined by regional total volume of distribution (VT) at each lung scan.
Measured: Baseline to up to 28 days post-dose
Secondary outcomes (4)
The relationship between PIPE-791 plasma concentration and brain and lung LPA1 occupancy.
Measured: Baseline to up to 28 days post-dose
The PIPE-791 EC50 (i.e., the plasma concentration of PIPE-791 associated with 50% occupancy of LPA1) in the brain and lungs.
Measured: Baseline to up to 28 days post-dose
Pharmacokinetics (PK): blood concentration levels of PIPE-791
Measured: Baseline to up to 28 days post-dose
Safety and tolerability: Treatment-Emergent Adverse Events (TEAE)
Measured: Baseline to up to 32 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start9 Dec 2024
- Primary completion4 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contineum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Huhn, MD, Study director, Contineum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683612
- Sponsor's protocol ID
- CTX-791-102
- Status last verified
- Aug 2025
- First submitted
- 6 Nov 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06683612
- Acronym / sponsor ID
- CTX-791-102
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Pulmonary Fibrosis, Multiple Sclerosis, Multiple Sclerosis, MS, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Progressive
- Keywords
- remyelination, MS, multiple sclerosis, PrMS, PPMS, SPMS, primary progressive MS, primary progressive multiple sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Contineum TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 12 Nov 2024 (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.
This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.
Participants will:
- Take a single dose of the study drug
- Give many samples of blood and urine
- Have multiple PET scans
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers, brain PET imaging | Experimental | Drug: PIPE-791 |
| Healthy volunteers, lung PET imaging | Experimental | Drug: PIPE-791 |
| Volunteers with PrMS | Experimental | Drug: PIPE-791 |
| Volunteers with IPF | Experimental | Drug: PIPE-791 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PIPE-791Subjects will receive a single oral dose of PIPE-791. | Drug | Healthy volunteers, brain PET imaging, Healthy volunteers, lung PET imaging, Volunteers with IPF, Volunteers with PrMS |
Primary outcome
LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.
Time frame: Baseline to up to 28 days post-dose
LPA1 occupancy as determined by regional total volume of distribution (VT) at each lung scan.
Time frame: Baseline to up to 28 days post-dose
4 secondary outcomes
The relationship between PIPE-791 plasma concentration and brain and lung LPA1 occupancy.
Time frame: Baseline to up to 28 days post-dose
The PIPE-791 EC50 (i.e., the plasma concentration of PIPE-791 associated with 50% occupancy of LPA1) in the brain and lungs.
Time frame: Baseline to up to 28 days post-dose
Pharmacokinetics (PK): blood concentration levels of PIPE-791
Time frame: Baseline to up to 28 days post-dose
Safety and tolerability: Treatment-Emergent Adverse Events (TEAE)
Time frame: Baseline to up to 32 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Stephen Huhn, MD study director
Contineum Therapeutics
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 PIPE-791 in people with Idiopathic Pulmonary Fibrosis (IPF) and Idiopathic Pulmonary Fibrosis, run by Contineum Therapeutics 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?
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: finished, as of the sponsor's last update on 6 Aug 2025. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan. (time frame: Baseline to up to 28 days post-dose). The study lists 2 primary outcomes in all. 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 6 Aug 2025.