Safety, Tolerability, and Pharmacokinetics of Ent001 in Moderate to Severe Ulcerative Colitis Patients

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of Ent001 in patients diagnosed with moderately to severely active **ulcerative colitis**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with Ent001, which could inform treatment strategies for managing this chronic inflammatory bowel disease. No secondary objectives are provided in the available data.

The clinical trial involves a total of **15 participants** diagnosed with **inflammatory bowel disease**, specifically moderate to severe active **ulcerative colitis**. The study population includes both male and female subjects, with an age range that corresponds to categories 3 and 4, indicating a broad age spectrum. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetics of Ent001 in patients diagnosed with moderately to severely active **ulcerative colitis**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is January 22, 2024, with an anticipated completion date of August 31, 2025. Participants will be involved in the study for the duration of the trial, which spans approximately 19 months.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Throughout the trial, participants will attend regular follow-up visits to monitor their response to the treatment and to assess any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The trial will conclude with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the treatment.

Participant involvement is expected to last until the end of the study unless specific conditions necessitate early termination. Such conditions may include the occurrence of significant adverse events, withdrawal of consent, or non-compliance with the study protocol. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. As such, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on January 22, 2024, with an estimated end date of August 31, 2025. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the available information. The trial will adhere to rigorous standards typical of Phase 3 studies to ensure the reliability and validity of the efficacy data collected.