BAY3389934 / Sepsis / Coagulopathy · Phase 1 Trial

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

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 1 study that is currently recruiting participants to evaluate the safety, tolerability, and suitable dose of BAY 3389934 in hospitalised patients with sepsis-induced coagulopathy. No results are yet posted in this registry record. The study is designed to collect adverse event data over approximately 28 days of follow-up.

What was studied

Phase 1, Interventional, Non Randomized, Sequential, Open label, Basic Science purpose. Sepsis, Coagulopathy; age from 18 Years; to 80 Years. Intervention: Cohort 1 of BAY3389934; Cohort 2 of BAY3389934. n = 36. 20 sites across 4 countries.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This registry record describes planned work only and does not provide evidence for clinical decision-making. Once results are posted, they will inform early safety and dose-selection decisions for BAY 3389934 in this indication but are unlikely to guide therapeutic use until Phase 2/3 efficacy data are available.

Plain-language summary

First-in-patient Phase 1 safety and dose-finding study with no results posted; designed to establish safety and tolerability of BAY 3389934 in sepsis-induced coagulopathy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: The number of participants with TEAEs (treatment-emergent adverse events) (assessed at After the first administration of study intervention to 1 hour after stop from…); Severity of TEAEs (assessed at After the first administration of study intervention to 1 hour after stop from…)

DesignPhase 1, Interventional, Non Randomized, Sequential, Open label, Basic Science purpose

PopulationSepsis, Coagulopathy; age from 18 Years; to 80 Years

Sample size36

InterventionCohort 1 of BAY3389934; Cohort 2 of BAY3389934

Setting20 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment36

PhasePhase 1

Primary outcome measure 1Number of participants with treatment-emergent adverse events (TEAEs) from first administration to 1 hour after study intervention stop, up to 97 hours

Primary outcome measure 2Severity of treatment-emergent adverse events (TEAEs) from first administration to 1 hour after study intervention stop, up to 97 hours

Planned follow-up durationapproximately 28 days

Clinical bottom line

Caveats

No results are posted; this is a study registration only.
Phase 1 design limits inference about efficacy or clinical benefit.
Specific inclusion and exclusion criteria are not detailed in the registry record.
No comparator arm described; this appears to be a single-arm dose-escalation study.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design with planned dose escalation; appropriate for first-in-patient.

Directness

strong

Primary outcomes directly measure safety and tolerability in target population with sepsis-induced coagulopathy.

Consistency

insufficient

Registry record only; no results posted for comparison with other data.

Risk of bias

insufficient

No results reported; blinding status and analysis methods not specified in registry record.

Sample adequacy

limited

36 participants estimated; typical for Phase 1 dose-escalation but underpowered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06854640). This is a study registration, not published results. Lead sponsor: Bayer. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Sepsis, Coagulopathy. Interventions: DRUG: BAY3389934. Primary outcome measures: 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. Brief summary: 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)

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06854640BAY3389934SepsisBayerCoagulopathy