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A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT07118878•Agomab Spain S.L.U.

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

SGS Belgium

Edegem, Belgium

Key Dates

Start Date

August 6, 2025

Primary Completion Date

September 15, 2025

Completion Date

September 15, 2025

Last Updated

November 21, 2025

Enrollment

ACTUAL participants

Conditions

Fibrostenotic Crohn's Disease

Interventions

AGMB-129

DRUG

Placebo

OTHER