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

NCT07118878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-21

No results posted yet for this study

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

Interventions

DRUG

AGMB-129

AGMB-129

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Agomab Spain S.L.U.

    lead INDUSTRY

Principal Investigators

  • Carmen Fleurinck, MD · Agomab Spain SL

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118878 on ClinicalTrials.gov