Safety Evaluation of SOR102 in Healthy Subjects and Ulcerative Colitis Patients: A Phase I Clinical Trial

The primary objective of this clinical trial is to assess the **safety** of SOR102 in both healthy participants and patients diagnosed with **ulcerative colitis**. Evaluating the safety profile of SOR102 is clinically relevant as it provides essential information on the potential risks and adverse effects associated with the treatment, which is crucial for determining its suitability for further clinical development and eventual therapeutic use in managing ulcerative colitis.

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 of 18 to 65 years. 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 aims to gather data from a diverse group within the specified age range, ensuring a comprehensive understanding of the condition across different demographics.

The clinical trial is designed to evaluate the safety of a new investigational product, SOR102, in both healthy participants and patients diagnosed with **ulcerative colitis**. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research focusing on safety and dosage. The trial is expected to commence recruitment on May 28, 2024, and is projected to conclude by March 1, 2025. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to maintain the integrity of the data collected.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, potential participants will be assessed against the inclusion and exclusion criteria to determine their eligibility for the trial. Once enrolled, participants will attend scheduled follow-up visits, which are essential for monitoring their health status, assessing the safety of the investigational product, and collecting necessary data. The sequence and frequency of these visits will be determined by the study protocol, ensuring comprehensive monitoring throughout the trial duration. The end-of-study visit marks the final assessment, where participants will undergo a thorough evaluation to conclude their involvement in the study.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. However, participants are generally expected to remain in the study until its completion unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the investigational product, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants throughout the study period.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or 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 May 28, 2024, with an anticipated end date of March 1, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy through various measures. These may include symptom improvement scores, biomarker levels, or other relevant clinical indicators, depending on the investigational product and the condition being studied. The methods for measuring and analyzing these parameters are typically aligned with standard clinical practices, utilizing validated scales, laboratory tests, or patient-reported outcomes. The schedule for these assessments is generally structured around key timepoints throughout the trial duration, ensuring systematic data collection and analysis. The trial's design and execution adhere to regulatory standards and scientific rigor, ensuring the reliability and validity of the efficacy assessments conducted during the study period.