A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants
- Conditions
- Fibrostenotic Crohn's Disease
- Interventions
- Other: Placebo
- Registration Number
- NCT07118878
- Lead Sponsor
- Agomab Spain S.L.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description AGMB-129 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 Placebo 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
- Primary Outcome Measures
Name Time Method Number of participant with Adverse Events 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
Number of participant with abnormal Physical examination 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
Number of participant with abnormal Vital signs From enrollment to the end of treatment at 42 days To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
Number of participant with abnormal electrocardiograms (ECGs) parameters 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
Number of participant with abnormal 2-dimensional (2-D) echocardiography 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
Number of participant with abnormal clinical laboratory tests 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 Outcome Measures
Name Time Method Plasma levels of AGMB-129 From enrollment to the end of treatment at 42 days To characterize the pharmacokinetics (PK) of AGMB-129 by measuring the amount in plasma
Plasma levels of metabolite MET-154 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
Plasma levels of metabolite MET-158 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
Trial Locations
- Locations (1)
SGS Belgium
🇧🇪Edegem, Belgium
SGS Belgium🇧🇪Edegem, BelgiumLotte VerwilligenContact