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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521705-40-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGMB-129 | Drug | AGMB-129 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant with Adverse Events | To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit | 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 | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of AGMB-129 | To characterize the pharmacokinetics (PK) of AGMB-129 by measuring the amount in plasma | From enrollment to the end of treatment at 42 days |
| Plasma levels of metabolite MET-158 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Fleurinck, MD | Agomab Spain SL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium | Edegem | Belgium |
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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.
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The participants, investigator(s), blinded monitors, and employees of the site involved in the management of the study will be blinded to intervention, unless in case of emergency.
| Other |
Placebo |
|
To characterize the pharmacokinetics (PK) of metabolite MET-158 by measuring the amount in plasma
| 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 | From enrollment to the end of treatment at 42 days |