Evaluation of Safety, Engraftment, and Initial Clinical Activity of MB310 in Patients with Active Mild to Moderate Ulcerative Colitis: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate the **safety** and **engraftment** of MB310 in patients with active, mild to moderate **Ulcerative Colitis**. This is clinically relevant as it aims to determine the potential of MB310 to be a safe and effective treatment option for managing symptoms and improving the quality of life in patients with this chronic inflammatory bowel disease. The study also seeks to observe initial signs of clinical activity, which could provide early insights into the therapeutic potential of MB310 in this patient population.

The clinical trial involves a total of **9 participants** diagnosed with **Ulcerative Colitis**. The study population includes both male and female subjects, with an age range that spans from adolescents to adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The general health status of the participants is not detailed, nor are any lifestyle considerations such as diet, physical activity, or habits. The trial does not specify any particular lifestyle factors that may influence the study outcomes.

The clinical trial is a **Phase 1b**, randomized, placebo-controlled, double-blind study designed to evaluate the safety, engraftment, and initial signs of clinical activity of MB310 in patients with active, mild to moderate **ulcerative colitis**. The trial is set to commence recruitment on August 7, 2024, and is expected to conclude by August 29, 2025. Participants will be randomly assigned to either the treatment group receiving MB310 or a placebo group, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the study.

The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before the initiation of the treatment phase. Throughout the study, participants will attend regular follow-up visits to monitor safety, assess engraftment, and evaluate any initial signs of clinical activity. These visits will include various assessments and data collection to ensure comprehensive monitoring of the participants' health and response to the treatment.

The expected duration of participant involvement in the study is approximately one year, from the initial screening visit to the end-of-study visit. The end-of-study visit will involve final assessments to gather data on the long-term effects and safety of the treatment. Participants may be subject to early termination from the study if they experience significant adverse events, fail to comply with study procedures, or withdraw consent. The study 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. As such, 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. Consequently, 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 through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is August 7, 2024, with an anticipated end date of August 29, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. The trial will likely employ standard methods for data collection and analysis, consistent with Phase 1 objectives, to gather initial insights into the treatment's potential effectiveness. The absence of detailed endpoints suggests a focus on exploratory outcomes, which may include biomarker assessments or preliminary symptom improvement observations. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the collected data.