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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Number of participant with Adverse Events
Timeframe: From enrollment to the end of treatment at 42 days
Number of participant with abnormal Physical examination
Timeframe: From enrollment to the end of treatment at 42 days
Number of participant with abnormal Vital signs
Timeframe: From enrollment to the end of treatment at 42 days
Number of participant with abnormal electrocardiograms (ECGs) parameters
Timeframe: From enrollment to the end of treatment at 42 days
Number of participant with abnormal 2-dimensional (2-D) echocardiography
Timeframe: From enrollment to the end of treatment at 42 days
Number of participant with abnormal clinical laboratory tests
Timeframe: From enrollment to the end of treatment at 42 days