Evaluation of the Pharmacokinetics and Safety of BAY3401016 in Healthy Male Subjects with Alport Syndrome

The primary objective of this study is to evaluate the **safety** profile of the investigational treatment BAY3401016 in healthy male participants. This involves assessing how the treatment affects the body and its pharmacokinetics, which includes the absorption, distribution, metabolism, and excretion of the drug. Understanding these parameters is crucial for determining the appropriate dosage and ensuring the treatment's safety before it can be considered for further clinical trials in patients with **Alport syndrome**. No secondary objectives are specified for this study.

The clinical trial focuses on **Alport syndrome**, a genetic condition affecting kidney function. The study population comprises male participants, specifically within the age range of 18 to 64 years, indicating a focus on adult males. The trial does not include vulnerable populations, and the sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any lifestyle considerations such as diet or physical activity, have not been disclosed. The absence of female participants is a notable aspect of the study design.

The clinical trial is designed to evaluate the **safety** and pharmacokinetics of the investigational treatment BAY3401016 in healthy male participants. This study is a **Phase 1** trial, which is typically the first stage of testing in human subjects and focuses on assessing the safety profile of the treatment. The trial is structured as a randomized, double-blind, and controlled study to ensure the reliability and validity of the results. The estimated duration of the trial spans from May 29, 2023, to May 27, 2025, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This initial visit will involve a thorough assessment to ensure participants meet the necessary health standards for trial inclusion. Following the screening, participants will be randomly assigned to receive either the investigational treatment or a placebo, with neither the participants nor the researchers aware of the group assignments, maintaining the double-blind nature of the study.

Throughout the trial, participants will attend scheduled follow-up visits to monitor their health status and collect data on the treatment's effects. These visits are crucial for evaluating the treatment's pharmacokinetics, which involves understanding how the drug is absorbed, distributed, metabolized, and excreted by the body. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment's safety and efficacy.

The expected length of participant involvement in the trial is approximately two years, contingent upon adherence to the study protocol. Conditions that may lead to early termination from the study include adverse reactions to the treatment, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are meticulously crafted to ensure the collection of high-quality data while prioritizing participant safety and well-being.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the provided data, further details about the experimental and non-experimental treatments, including their administration and monitoring, cannot be elaborated upon. The trial documentation should be consulted for comprehensive information regarding the treatments used in this 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 trial is scheduled to commence recruitment on May 29, 2023, with an estimated completion date of May 27, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary efficacy data alongside safety assessments. The methods for measuring and analyzing efficacy will likely include standardized clinical assessments and potentially the use of validated scales or laboratory tests, consistent with the practices in early-phase trials. The trial's design will ensure that data collection is systematic and aligned with regulatory standards, although specific tools or instruments for efficacy assessments are not specified in the available data.