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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-06

Study Completion Date

2025-09-15

Brief Summary

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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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Detailed Description

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Conditions

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Fibrostenotic Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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AGMB-129

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

Group Type EXPERIMENTAL

AGMB-129

Intervention Type DRUG

AGMB-129

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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AGMB-129

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes