Evaluation of Tolerability and Safety of BI 3802876 in Healthy Male Volunteers

The primary objective of this study is to evaluate the **tolerability** of different doses of BI 3802876 in healthy male volunteers. Understanding the tolerability of this compound is clinically relevant as it provides foundational safety data necessary for the development of potential therapeutic applications. This study does not list any secondary objectives.

The clinical trial involves a study population of **healthy volunteers**. The participants are exclusively male, with an age range corresponding to category code 3, which typically includes adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. The trial does not include female subjects, and no significant inclusion or exclusion criteria have been specified by the sponsor.

The clinical trial is designed as a **randomized**, double-blind, controlled study to evaluate the tolerability of different doses of BI 3802876 in healthy male volunteers. The trial is categorized as a Phase 1 study, focusing on pharmacokinetic assessments. The estimated recruitment start date is November 17, 2023, with an anticipated completion by April 14, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their continued eligibility and adherence to the study protocol.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit ensures that only suitable candidates are enrolled in the trial. Following successful screening, participants will undergo a series of follow-up visits, which are scheduled to monitor their response to the investigational product and to collect necessary data for the study's objectives. These visits are crucial for evaluating the safety and tolerability of the administered doses.

The end-of-study visit marks the conclusion of a participant's involvement in the trial. During this visit, final assessments are conducted to gather comprehensive data on the participant's health status and any potential effects of the investigational product. Participants may be withdrawn from the study prior to its completion if they experience adverse events, fail to comply with the study protocol, or choose to withdraw consent. The trial's design and procedures are structured to ensure the collection of high-quality data while maintaining participant safety and adherence to ethical standards.

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 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 November 17, 2023, with an anticipated end date of April 14, 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. The trial will likely employ standard methodologies 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 initial symptom improvement observations. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the collected data.