Clinical trials

Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the efficacy, safety, and dose-response relationship of ontunisertib in participants with CD and symptomatic strictures, and contribute to the validation of novel endpoints to assess potential treatment benefit in patients with fibrostenosing Crohn's disease (FSCD). The participants will be in the trial for a duration of up to 60 weeks, consisting of a 6-week screening period (with 2 screening visits), a 52-week treatment period, and a 2-week follow-up period. The visit frequency in the treatment period will be every 6 to 8 weeks.

The main goal of this clinical trial is to find out if an experimental inhaled drug, AGMB-447, can help improve lung function in people living with a lung disease called idiopathic pulmonary fibrosis (IPF). To do this, the effects of the study drug will be compared to a placebo, which is a treatment that looks like the study drug but contains no active medicine. The specific goals of the trial are as follows: Primary Objective and Estimand: The main goal is to see if 24 weeks of treatment with AGMB-447 helps the lungs work better than a placebo. This is measured by checking the total amount of air a person can forcefully blow out after taking a deep breath. The study will measure this effect for all participants who start the trial, regardless of whether they are able to finish the full 24 weeks of treatment or if they need to change their other medications during the study. Secondary Objective: The trial also aims to measure how much of the study drug is in the blood at different times. This helps researchers understand how the drug is absorbed and processed by the body after it is inhaled. In addition, the trial aims to evaluate if the treatment is safe and well-tolerated.

This is an open, two-part study in healthy male volunteers, aged 30-65 years. This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine (\[14C\]ontunisertib) and determine the routes and rates of elimination of the test medicine.