Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Early safety check for new sepsis clotting drug

NCT ID NCT07176728

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called BAY 3389934 in 16 healthy Japanese adults to see if it is safe and how the body handles it. The drug is being developed to treat a serious blood clotting condition that can happen with severe infections (sepsis). Participants received either the drug or a placebo through an IV, and researchers monitored for side effects and measured drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Sep 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sepsis associated disseminated intravascular coagulation (DIC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

disseminated intravascular coagulation Sepsis vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis associated disseminated intravascular coagulation (DIC)

Contacts and locations

Locations

  • SOUSEIKAI Fukuoka Mirai Hospital

    Fukuoka, Fukuoka Pref, 813-0017, Japan

  • SOUSEIKAI Fukuoka Mirai Hospital

    Fukuoka, 813-0017, Japan