Evaluation of Tolerability and Safety of BI 3810477 in Healthy Male Volunteers

The primary objective of this study is to evaluate the **tolerability** of different doses of BI 3810477 in healthy male volunteers. Understanding the tolerability of BI 3810477 is clinically relevant as it provides foundational safety data necessary for the development of this compound, potentially informing future therapeutic applications. No secondary objectives are specified for this study.

The clinical trial involves a study population of **healthy volunteers**. The trial is exclusively composed of male participants, with an age range categorized as adults. The sponsor did not provide information regarding the total number of participants. The selection process for the trial population is not detailed, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The trial does not include vulnerable populations, and no significant inclusion or exclusion criteria have been highlighted. The sponsor has not disclosed the main objective of the trial.

The clinical trial is designed to evaluate the **tolerability** of varying doses of BI 3810477 in healthy male volunteers. This is a Phase 1 trial, which is typically the first stage of testing in human subjects and focuses on assessing safety and dosage. The trial is structured as a randomized, double-blind, controlled study to ensure unbiased results and to maintain the integrity of the data collected. The estimated recruitment start date is November 4, 2024, with an anticipated end date of July 21, 2025, indicating a total trial duration of approximately nine months.

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 study. Once enrolled, participants will attend follow-up visits at predetermined intervals to monitor their response to the investigational product and to collect data on safety and tolerability. The sequence and frequency of these visits are designed to ensure comprehensive monitoring throughout the trial period. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather concluding data on the investigational product's effects.

The expected length of participant involvement will vary depending on the specific dosing schedule and follow-up requirements, but it is anticipated to span several months. Conditions that may lead to early termination from the study 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 and regulatory standards 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, 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 treatments 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 offered regarding these aspects of the clinical trial.

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 November 4, 2024, with an anticipated end date of July 21, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to gather data on the investigational product's effects. The schedule for measuring and collecting efficacy data is not specified, but it is common for such trials to include multiple timepoints throughout the study duration to monitor changes and trends. The analysis of collected data will likely involve statistical methods appropriate for early-phase trials, focusing on identifying any initial signs of efficacy that warrant further investigation in subsequent trial phases.