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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Bayer
Study ID
NCT06854640
Phase
PHASE1
Status
Recruiting
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Conditions

  • Coagulopathy
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • BAY3389934 — DRUG
    Solution for IV infusion

Study Details

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)

Key Dates

First listed
Mar 3, 2025
Start date
Mar 12, 2025
Status verified
Aug 2026
Primary completion
Dec 25, 2026
Completion
Jan 17, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1 of BAY3389934
    Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.
  • Experimental: Cohort 2 of BAY3389934
    Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Health University of Colorado Hospital - Medical Intensive Care UnitAuroraColorado80045-

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UC Health University of Colorado Hospital - Medical Intensive Care Unit· Aurora, CO

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