(21751) First-in-human single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 3018250 in healthy men in a randomized, placebo-controlled, single-blind, group-comparison design

The primary objective of this study is to evaluate the **safety** and pharmacokinetics of the investigational treatment BAY3018250 in healthy male subjects. This is a first-in-human trial designed to assess how the treatment is absorbed, distributed, metabolized, and excreted when administered in single, increasing doses compared to a placebo. Understanding the safety profile and pharmacokinetics is crucial for determining the potential therapeutic application of BAY3018250 in conditions such as **acute ischemic stroke**. The study does not specify any secondary objectives.

The clinical trial focuses on **acute ischemic stroke** and involves a study population consisting exclusively of male participants. The age range of the participants is categorized as adults, specifically those aged 18 to 64 years. The trial does not include a vulnerable population, and the general health status of the participants is not specified. The total number of participants is not provided, as the sponsor has not disclosed this information. The selection criteria for the trial population, including any relevant lifestyle considerations such as diet, physical activity, or habits, are not detailed in the available data. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed as a **randomized**, **double-blind**, and **placebo-controlled** study to evaluate the safety, pharmacokinetics, and pharmacodynamics of the investigational treatment BAY3018250 in healthy male participants. The trial is a **Phase 1** study, focusing on the administration of single, increasing doses of the study drug compared to a placebo. The trial is set to commence recruitment on November 9, 2022, with an estimated completion date of July 13, 2023, indicating an overall trial duration of approximately eight months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either the investigational treatment or placebo. Subsequent visits will be scheduled to monitor safety, collect pharmacokinetic and pharmacodynamic data, and assess any adverse events. These follow-up visits are critical for ensuring participant safety and collecting necessary data to evaluate the study objectives.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. This visit will include a final assessment of the participant's health status and the collection of any remaining data. The expected length of participant involvement from the initial screening to the end-of-study visit is contingent upon the dosing schedule and follow-up requirements, typically spanning several weeks to a few months. Participants may be subject to early termination from the study if they experience significant adverse events, withdraw consent, or fail to comply with study procedures. The trial is conducted under strict ethical guidelines and regulatory standards to ensure the safety and well-being of all participants.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a clinical trial description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was November 9, 2022, with an estimated end date of July 13, 2023. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve the collection of preliminary data on the treatment's effects. The trial will likely employ standard methods for measuring and analyzing efficacy, which may include validated scales, laboratory tests, or other relevant instruments, depending on the investigational product and the condition being studied. The schedule for these assessments would be aligned with the trial's protocol, ensuring systematic data collection and analysis throughout the study duration.