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Completed

NCT Number: NCT07118878

A Multiple Ascending Dose Study With 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.

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Key information

Conditions

Fibrostenotic Crohn's Disease

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium

Edegem, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

AGMB-129

Drug

AGMB-129

Placebo

Other

Placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Plasma levels of AGMB-129

    Time frame: From enrollment to the end of treatment at 42 days

    To characterize the pharmacokinetics (PK) of AGMB-129 by measuring the amount in plasma

  2. Plasma levels of metabolite MET-158

    Time frame: From enrollment to the end of treatment at 42 days

    To characterize the pharmacokinetics (PK) of metabolite MET-158 by measuring the amount in plasma

  3. Plasma levels of metabolite MET-154

    Time frame: From enrollment to the end of treatment at 42 days

    To characterize the pharmacokinetics (PK) of metabolite MET-158 by measuring the amount in plasma

Sponsors and collaborators

Lead sponsor

Agomab Spain S.L.U.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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