A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants

Agomab Spain S.L.U.

Status and phase: Completed; Phase 1

Conditions: Fibrostenotic Crohn's Disease

Treatments: Other: Placebo; Drug: AGMB-129

Study type: Interventional

Funder types: Industry

Identifiers

NCT07118878

AGMB129-01-CL-109

2025-521705-40-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Between 18 and 55 years of age (extremes included), at the time of signing the informed consent.
2. 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.
3. Male or female

Exclusion criteria

1. Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
2. 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.
3. History of or a current immunosuppressive condition, including a positive test for HIV-1 or HIV-2 antibodies at screening.
4. 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

AGMB-129

Experimental group

Description:

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

Treatment:

Drug: AGMB-129

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo