NCT07118878CompletedPhase 1
A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants
A Phase 1, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AGMB-129 in Healthy Participants
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 28 Jul 2025
- Start date
- 6 Aug 2025
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Agomab Spain S.L.U.
- Diseases
- Crohn's disease
- NCT number
- NCT07118878
- EU CT number
- 2025-521705-40-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 6 Aug 2025 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
- History of or a current immunosuppressive condition, including a positive test for HIV-1 or HIV-2 antibodies at screening.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SGS Belgium Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.