A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy

Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.

Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.

The main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).

For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.

Participants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.

Each participant will be in the study for around 28 days. During the study, the doctors and their study team will:

• Take blood and urine samples,
• Do physical examinations,
• Check vital signs such as body temperature, blood pressure and heart rate,
• Examine heart health using electrocardiogram (ECG)

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Coagulopathy
• Intervention / Treatment: Drug: BAY3389934

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Not yet recruiting
    • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • UZ Antwerpen - Intensive Care
  • Liège, Belgium, 4000
    • Not yet recruiting
    • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
  • Ottignies-Louvain-la-Neuve, Belgium, 1340
    • Recruiting
    • Clinique Saint-Pierre d'Ottignies - Intensive Care
• France
  • Centre-Val de Loire
    • Tours, Centre-Val de Loire, France, 37044
      • Not yet recruiting
      • CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
  • Grand Est
    • Strasbourg, Grand Est, France, 67091
      • Recruiting
      • Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
  • New Aquitaine
    • Limoges, New Aquitaine, France, 87042
      • Not yet recruiting
      • Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
  • Pays de la Loire Region
    • Angers, Pays de la Loire Region, France, 49100
      • Not yet recruiting
      • Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
    • La Roche-sur-Yon, Pays de la Loire Region, France, 85000
      • Not yet recruiting
      • Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
    • Nantes, Pays de la Loire Region, France, 44000
      • Not yet recruiting
      • Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
  • Île-de-France Region
    • Garches, Île-de-France Region, France, 92380
      • Not yet recruiting
      • Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
• Germany
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin
  • München, Germany, 81377
    • Not yet recruiting
    • Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 51109
      • Not yet recruiting
      • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Not yet recruiting
      • Universitair Medisch Centrum St. Radboud - Intensive Care
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Not yet recruiting
      • Canisius WIlhelmina Ziekenhuis - Intensive Care
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
      • Not yet recruiting
      • Jeroen Bosch Ziekenhuis - Intensive Care
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Not yet recruiting
      • Medisch Spectrum Twente - Intensive Care
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Not yet recruiting
      • Erasmus Medisch Centrum - Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.
• Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
• participants with suspected or documented origin of infection.
• Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000/mm3 to < 150,000/mm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be < 30,000/mm3.
• Participants must be receiving treatment in an ICU.
• Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.

Exclusion Criteria:

• Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.
• Low platelets level or abnormal coagulation status due to any other reason than sepsis.
• Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists/warfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin
• Any active malignancy
• Pregnancy or breastfeeding.
• Chronic liver disease Child-Pugh Class C.
• Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery/trauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.
• Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 of BAY3389934; Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.	Drug: BAY3389934; Solution for IV infusion
Experimental: Cohort 2 of BAY3389934; Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.	Drug: BAY3389934; Solution for IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants with TEAEs (treatment-emergent adverse events)	After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Severity of TEAEs	After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Activated partial thromboplastin time (aPTT)	From the first administration of study intervention day 1 to day 6
Prothrombin time (PT)	From the first administration of study intervention day 1 to day 6

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: DIC; Disseminated intravascular coagulation; Sepsis induced coagulopathy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Thrombophilia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Hemostatic Disorders; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 22265 (City of Hope Medical Center); 2024-515635-30-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No