Fibrostenotic Crohn's DiseasePhase 1NCT07118878
A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants
A Phase 1 study testing AGMB-129 in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 1 site in Belgium.
Trial summary
In patients with Crohn's disease (CD), fibrosis of the gastrointestinal (GI) tract can result in stricture (stenosis) formation and obstruction of the GI tract, causing obstructive symptoms and often requiring surgical intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrostenotic Crohn's Disease
- What is being tested?
- AGMB-129
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Aug 2025to 15 Sep 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 55 years of age (extremes included), at the time of signing the informed consent.
- Body weight of at least 50.0 kg for men and 45.0 kg for women, and a BMI between 19.0 and 30.0 kg/m2 (extremes included) at screening.
- Male or female
Who cannot join
- Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
- Positive serology for HBsAg or anti-HCV antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first administration of study treatment.
- History of or a current immunosuppressive condition, including a positive test for HIV-1 or HIV-2 antibodies at screening.
- Presence or sequelae of gastrointestinal, liver, kidney (eGFR ≤80 mL/min/1.73 m² using the CKD-EPI formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening. Note: Participants who have an eGFR of up to 10% below 80 mL/min/1.73 m2 may be enrolled in the study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AGMB-129 in Healthy Participants
In patients with Crohn's disease (CD), fibrosis of the gastrointestinal (GI) tract can result in stricture (stenosis) formation and obstruction of the GI tract, causing obstructive symptoms and often requiring surgical intervention. There are currently no approved therapies for treating fibrostenotic Crohn's disease (FSCD) and therefore, there is an urgent need for safe and effective antifibrotic therapies.
AGMB-129 has shown to be safe in healthy participants with single doses up to 1200 mg and multiple doses up to 200 mg twice daily (BID) for 10 days, and in FSCD patients with multiple doses up to 200 mg BID for 12 weeks.
This Phase 1 study will explore the safety, tolerability, and pharmacokinetics (PK) of other daily doses of AGMB-129 in healthy participants to inform on dose selection (nominal dose and dosing frequency) for subsequent clinical trials.
- Conditions
- Fibrostenotic Crohn's Disease
- Being tested
- AGMB-129, Placebo
- Keywords
- FSCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGMB-129Drug
AGMB-129
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AGMB-129 | Experimental | participants will receive a single dose of AGMB-129 (reference cohort) for 7 consecutive days or multiple doses of AGMB-129 (cohort 1, 2, 3) for 7 consecutive days Receives: Drug: AGMB-129 |
| Placebo | Placebo comparator | participants will receive a single dose of placebo (reference cohort) for 7 consecutive days or multiple doses of placebo (cohort 1, 2, 3) for 7 consecutive days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with Adverse Events
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit
Measured: From enrollment to the end of treatment at 42 days
Number of participant with abnormal Physical examination
To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit
Measured: From enrollment to the end of treatment at 42 days
Number of participant with abnormal Vital signs
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
Measured: From enrollment to the end of treatment at 42 days
Number of participant with abnormal electrocardiograms (ECGs) parameters
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit
Measured: From enrollment to the end of treatment at 42 days
Number of participant with abnormal 2-dimensional (2-D) echocardiography
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit
Measured: From enrollment to the end of treatment at 42 days
Number of participant with abnormal clinical laboratory tests
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal clinical laboratory parameters at every visit
Measured: From enrollment to the end of treatment at 42 days
Secondary outcomes (3)
Plasma levels of AGMB-129
To characterize the pharmacokinetics (PK) of AGMB-129 by measuring the amount in plasma
Measured: From enrollment to the end of treatment at 42 days
Plasma levels of metabolite MET-158
To characterize the pharmacokinetics (PK) of metabolite MET-158 by measuring the amount in plasma
Measured: From enrollment to the end of treatment at 42 days
Plasma levels of metabolite MET-154
To characterize the pharmacokinetics (PK) of metabolite MET-158 by measuring the amount in plasma
Measured: From enrollment to the end of treatment at 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start6 Aug 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrostenotic Crohn's DiseaseStudies 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
- Model description
- This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety, tolerability, and PK of MADs of orally administered AGMB-129 compared with placebo in healthy participants. The study will evaluate up to 4 dose cohorts: 1 reference cohort with the reference dose of AGMB-129 BID and up to 3 MAD cohorts, including an optional cohort.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmen Fleurinck, MD, Study director, Agomab Spain SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118878
- Sponsor's protocol ID
- AGMB129-01-CL-109
- Other IDs
- 2025-521705-40-00, 2025
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AGMB-129 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07118878
- Acronym / sponsor ID
- AGMB129-01-CL-109
- Conditions
- Fibrostenotic Crohn's Disease
- Keywords
- FSCD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Agomab Spain S.L.U.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 12 Aug 2025 (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.
In patients with Crohn's disease (CD), fibrosis of the gastrointestinal (GI) tract can result in stricture (stenosis) formation and obstruction of the GI tract, causing obstructive symptoms and often requiring surgical intervention. There are currently no approved therapies for treating fibrostenotic Crohn's disease (FSCD) and therefore, there is an urgent need for safe and effective antifibrotic therapies.
AGMB-129 has shown to be safe in healthy participants with single doses up to 1200 mg and multiple doses up to 200 mg twice daily (BID) for 10 days, and in FSCD patients with multiple doses up to 200 mg BID for 12 weeks.
This Phase 1 study will explore the safety, tolerability, and pharmacokinetics (PK) of other daily doses of AGMB-129 in healthy participants to inform on dose selection (nominal dose and dosing frequency) for subsequent clinical trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety, tolerability, and PK of MADs of orally administered AGMB-129 compared with placebo in healthy participants. The study will evaluate up to 4 dose cohorts: 1 reference cohort with the reference dose of AGMB-129 BID and up to 3 MAD cohorts, including an optional cohort.
| Arm | Type | Receives |
|---|---|---|
| AGMB-129 | Experimental | Drug: AGMB-129participants will receive a single dose of AGMB-129 (reference cohort) for 7 consecutive days or multiple doses of AGMB-129 (cohort 1, 2, 3) for 7 consecutive days |
| Placebo | Placebo comparator | Other: Placeboparticipants will receive a single dose of placebo (reference cohort) for 7 consecutive days or multiple doses of placebo (cohort 1, 2, 3) for 7 consecutive days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18 and 55 years of age (extremes included), at the time of signing the informed consent.
- Body weight of at least 50.0 kg for men and 45.0 kg for women, and a BMI between 19.0 and 30.0 kg/m2 (extremes included) at screening.
- Male or female
Key exclusion criteria (4 listed)
- Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
- Positive serology for HBsAg or anti-HCV antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first administration of study treatment.
- History of or a current immunosuppressive condition, including a positive test for HIV-1 or HIV-2 antibodies at screening.
- Presence or sequelae of gastrointestinal, liver, kidney (eGFR ≤80 mL/min/1.73 m² using the CKD-EPI formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening. Note: Participants who have an eGFR of up to 10% below 80 mL/min/1.73 m2 may be enrolled in the study at the discretion of the investigator.
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 |
|---|---|---|
| AGMB-129AGMB-129 | Drug | AGMB-129 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Number of participant with Adverse Events
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit
Number of participant with abnormal Physical examination
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit
Number of participant with abnormal Vital signs
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
Number of participant with abnormal electrocardiograms (ECGs) parameters
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit
Number of participant with abnormal 2-dimensional (2-D) echocardiography
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit
Number of participant with abnormal clinical laboratory tests
Time frame: From enrollment to the end of treatment at 42 days
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal clinical laboratory parameters at every visit
3 secondary outcomes
Plasma levels of AGMB-129
Time frame: From enrollment to the end of treatment at 42 days
Plasma levels of metabolite MET-158
Time frame: From enrollment to the end of treatment at 42 days
Plasma levels of metabolite MET-154
Time frame: From enrollment to the end of treatment at 42 days
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 21 Nov 2025.
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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.
Carmen Fleurinck, MD study director
Agomab Spain SL
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 AGMB-129 in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 1 site in Belgium.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 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 Belgium. 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 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?
Number of participant with Adverse Events (time frame: From enrollment to the end of treatment at 42 days). The study lists 6 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 21 Nov 2025.