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Sepsis Associated Disseminated Intravascular Coagulation (DIC)Phase 1NCT07176728

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.

A Phase 1 study testing BAY 3389934 in people with Sepsis Associated Disseminated Intravascular Coagulation (DIC), run by Bayer at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different doses. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
BAY 3389934
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
2 sitesJapan
Study dates
22 Sep 2025to 17 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant must be 18 to 55 years of age inclusive.
  • Participants who are overtly healthy Japanese as determined by medical evaluation.
  • Body mass index (BMI) within the range 18 - 29.9 kg/m² (inclusive).
  • Male participants must agree to use specified contraception during the study and for at least 90 days plus 5 half-lives after.
  • Female participants must be a Woman of Nonchildbearing Potential (WONCBP).
  • Capable of giving signed informed consent.
  • Willing to comply with the requirements and restrictions listed in the protocol.

Who cannot join

  • Any medical disorder, condition, or history that would impair participation.
  • Known hypersensitivity to the study drug or its excipients.
  • Known disorders with increased bleeding risk or known congenital/acquired coagulation disorders.
  • Use of prescription drugs, over-the-counter drugs, or herbal products within 14 days or 5 half-lives before the study.
  • Clinically relevant findings in the ECG, such as a QTcF over 450 msec.
  • Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and admission.
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  • Diastolic blood pressure below 40 mmHg or above 90 mmHg at screening and admission.
  • Positive results for Hepatitis B, Hepatitis C, or HIV.
  • Positive drug screening, alcohol breath test, or urine cotinine test.
  • Clinically relevant deviations of the screened laboratory parameters from reference ranges at the screening visit.
  • Positive pregnancy test.
  • Donation of blood or plasma within specified timeframes before the study.
  • Lack of compliance with lifestyle restrictions (e.g., alcohol, specific foods, strenuous activity).
  • Previous participation in this or another clinical study within a specified timeframe.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • SOUSEIKAI Fukuoka Mirai Hospital

    Fukuoka, Fukuoka Pref, 813-0017

  • SOUSEIKAI Fukuoka Mirai Hospital

    Fukuoka, 813-0017

Other trials in Japan

About this study

Official title: A Single-blind, Placebo Controlled, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3389934 Intravenous Infusions in Healthy Japanese Participants.

This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different doses. BAY 3389934 is being developed for the potential treatment of a serious blood clotting condition called sepsis-associated disseminated intravascular coagulation (DIC). The research will be conducted as a single-blind, placebo-controlled, dose-escalation study. This means that participants will be randomly assigned to receive either the active drug (BAY 3389934) or a placebo (an inactive substance), and they will not know which one they are receiving. The study will involve up to 16 healthy male and female Japanese participants, aged between 18 and 55. The study consists of two parts, called dose steps. In the first step, participants will receive a single 4-hour intravenous (IV) infusion of BAY 3389934 at a dose of 15 mg/h, or a placebo. Based on the safety and tolerability results from this first step, a second, higher dose will be selected for the next group of participants in the second step. Throughout the study, researchers will closely monitor participants for any side effects (adverse events). They will also collect blood and urine samples to study how the drug is absorbed, distributed, and eliminated by the body (pharmacokinetics or PK) and what effects it has on the body's clotting system (pharmacodynamics or PD). This involves measuring specific substances in the blood, such as activated partial thromboplastin time (aPTT) and prothrombin time (PT). Participants will stay at the study center for 4 days and will have a follow-up visit 3 to 5 days after they are discharged. The information gathered from this study is crucial for the future clinical development of BAY 3389934 in Japan and for designing future studies in patients with septic DIC.

Being tested
BAY 3389934, Matching Placebo / Diluent
Keywords
Sepsis, Disseminated Intravascular Coagulation, Coagulopathy
Medical subject headings
Sepsis, Disseminated Intravascular Coagulation, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY 3389934Drug

    Solution for intravenous infusion

  • Matching Placebo / DiluentDrug

    Solution for intravenous infusion

Study groups in NCT07176728
Study groupRoleWhat they receive
Dose Step 1 BAY 3389934Experimental15 mg/h/ intravenous Single Dose for 4 h fasting
Receives: Drug: BAY 3389934
Dose Step 2 BAY 3389934ExperimentalMax. dose 35 mg / h / intravenous - actual dose will be determined after Dose Step 1 Single Dose for 4 h fasting
Receives: Drug: BAY 3389934
Dose Step 1 and Dose Step 2 PlaceboPlacebo comparatorPlacebo / intravenous Single Dose for 4 h Fasting
Receives: Drug: Matching Placebo / Diluent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Investigate the safety and tolerability of BAY 3389934 15 mg/h and a second, higher dose (will be determined based on the result of 15 mg/h dose step), 4-hours infusion, respectively.

    Measured: From start of study intervention until the follow-up visit (approximately 5 weeks)

Secondary outcomes (7)

  1. Pharmacokinetic (PK) Profile of BAY 3389934 - Cmax

    Maximum observed drug concentration (Cmax) within the given timeframe. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).

    Measured: From pre-dose (0 hours) up to 48 hours after start of infusion

  2. Pharmacokinetic (PK) Profile of BAY 3389934 - AUC

    Area under the concentration vs. time curve from zero to infinity (AUC) within the given timeframe. In the case of an unexpected event of e.g., an exceedingly large (>20%) extrapolated portion of AUC (AUC(tlast-∞)), the parameter AUC(0-tlast) may be evaluated as main parameter. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).

    Measured: From pre-dose (0 hours) up to 48 hours after start of infusion

  3. Pharmacokinetic (PK) Profile of BAY 3389934 - Cmax/D

    Maximum observed drug concentration (Cmax) divided by dose (Cmax/D) within the given timeframe. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).

    Measured: From pre-dose (0 hours) up to 48 hours after start of infusion

  4. Pharmacokinetic (PK) Profile of BAY 3389934 - AUC/D

    Area under the concentration vs. time curve from zero to infinity (AUC) divided by dose (AUC/D) in the given timeframe. In the case of an unexpected event of e.g., an exceedingly large (>20%) extrapolated portion of AUC (AUC(tlast-∞)), the parameter AUC(0-tlast) may be evaluated as main parameter. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).

    Measured: From pre-dose (0 hours) up to 48 hours after start of infusion

  5. Pharmacokinetic (PK) Profile of BAY 3389934 - t 1/2

    Half-life associated with the terminal slope (t1/2) of BAY 3389934 in plasma within the given timeframe.

    PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).

    Measured: From pre-dose (0 hours) up to 48 hours after start of infusion

  6. Pharmacodynamic (PD) Profile of BAY 3389934 - aPTT

    Measure Activated partial thromboplastin time (aPTT). Assessed as the maximal ratio to baseline and the ratio to baseline at 4 hours and 5 hours after beginning of infusion.

    Measured: From pre-dose up to 5 hours after beginning of infusion.

  7. Pharmacodynamic (PD) Profile of BAY 3389934 - PT

    Prothrombin time (PT). Assessed as the maximal ratio to baseline and the ratio to baseline at 4 hours and 5 hours after beginning of infusion.

    Measured: From pre-dose up to 5 hours after beginning of infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start22 Sep 2025
  3. Primary completion17 May 2026
  4. Study completion17 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176728
Sponsor's protocol ID
22371
Status last verified
Jun 2026
First submitted
29 Aug 2025
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.vivli.org 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 member section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY 3389934 in people with Sepsis Associated Disseminated Intravascular Coagulation (DIC), run by Bayer at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From start of study intervention until the follow-up visit (approximately 5 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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