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

NCT07118878 | Completed Phase 1 DMC

• 2 other identifiers: AGMB129-01-CL-1092025-521705-40-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrostenotic Crohn's Disease

Keywords

FSCD

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (3)

• Plasma levels of AGMB-129

  From enrollment to the end of treatment at 42 days

• Plasma levels of metabolite MET-158

  From enrollment to the end of treatment at 42 days

• Plasma levels of metabolite MET-154

  From enrollment to the end of treatment at 42 days

Study Arms (2)

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

Drug: AGMB-129

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

Other: Placebo

Interventions

AGMB-129 DRUG

AGMB-129

AGMB-129

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agomab Spain S.L.U.: lead

Study Sites (1)

SGS Belgium

Edegem, Belgium

Location

Study Officials

• Carmen Fleurinck, MD

  Agomab Spain SL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 12, 2025
• Study Start: August 6, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

BE (1)