Safety, Dose-Finding, and Pharmacodynamic Study of BAY 3389934 in Patients with Sepsis-Associated Coagulopathy

The primary objective of this study is to evaluate the **safety** and determine the appropriate **dose** of BAY 3389934 in participants diagnosed with **sepsis** and **coagulopathy**. This is clinically relevant as sepsis, a life-threatening condition caused by the body's response to infection, often leads to coagulopathy, a disorder affecting blood clotting. Understanding the safety profile and optimal dosing of BAY 3389934 could potentially improve therapeutic strategies for managing these conditions.

The clinical trial involves participants diagnosed with **coagulopathy** and **sepsis**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population is noted to include vulnerable groups, although specific details regarding the selection process or lifestyle considerations such as diet or physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study.

The clinical trial is designed to evaluate the safety, appropriate dosage, and effects of BAY 3389934 in participants diagnosed with **sepsis** and **coagulopathy**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is March 10, 2025, with an anticipated completion date of May 10, 2026. 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 (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized and commence the treatment phase. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health status, treatment adherence, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The trial will conclude with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes and safety of the intervention.

Participant involvement is expected to last until the end of the study, unless early termination is warranted. Conditions that may lead to early withdrawal include significant adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, maintaining the integrity and scientific validity of the research.

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 treatment. 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.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date is March 10, 2025, with an anticipated end date of May 10, 2026. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically focus on confirming the effectiveness of a treatment, monitoring side effects, and collecting information that will allow the treatment to be used safely. The trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the disease, using scientifically validated methods and tools appropriate for the condition under investigation. The trial's design will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.