Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A first in human single dose escalation study to investigate the safety, tolerability, pharmacokinetics, and pharmcodynamics of BAY 3389934 compared with placebo.

This study is a very early step in testing a new medicine, BAY 3389934, in humans for the first time. It's designed for people who have a severe condition called sepsis-associated disseminated intravascular coagulation (DIC). In this condition, serious infection leads to widespread blood clotting problems. The main aims are to check if the new medicine is safe, how well people tolerate it, and how it moves through and affects the body. Researchers will compare it to a dummy medicine (placebo). This initial study helps scientists understand if the medicine shows promise before testing it in larger groups of people. It's an important step in finding new ways to treat this serious illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bayer AG

Enrolment target

Start

21 Jul 2023

Sepsis associated disseminated intravascular coagulation

What is this study about?

This study is about a new medicine called BAY 3389934. It's being developed to help people with a serious condition called sepsis-associated disseminated intravascular coagulation, often shortened to DIC. Sepsis is a life-threatening reaction to an infection, and DIC can happen alongside it, causing problems with blood clotting and bleeding throughout the body.

This particular study is a very early stage of testing, often called a 'Phase 1' study. This means it's the first time this new medicine is being given to people. The main goal here isn't to see if it cures the condition, but to carefully check if it's safe to use, if there are any side effects, and how much of the medicine the body can handle without problems. They also want to understand how the medicine moves through the body and what effects it has.

By comparing the new medicine to a 'placebo' (a dummy medicine that looks the same but has no active ingredients), researchers can get a clear idea of the medicine's effects. This careful, step-by-step testing is crucial for ensuring that any new medicines developed are as safe and effective as possible for patients in the future.

Key takeaways

This is a first-time human trial for a new medicine called BAY 3389934.
The medicine is for a serious blood clotting condition linked to severe infection (sepsis-associated DIC).
The study aims to check the medicine's safety, how the body handles it, and its effects.
Participants will receive either the new medicine or a placebo (dummy drug).
It's a very early research stage and will help scientists develop future treatments.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Because this is an early study of a new medicine for a specific, serious condition, there will likely be very specific health requirements that you would need to meet. For example, doctors would need to confirm that you have sepsis-associated DIC.

There might also be certain health conditions or medications that would prevent you from taking part, to ensure your safety. A study doctor would review all your medical information carefully to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of sepsis-associated DIC?
Are you able to attend all required study appointments?
Are you willing for your health to be closely monitored during the study?
Are you able to understand and sign the consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine, BAY 3389934, or a placebo (a dummy medicine). You wouldn't know which one you are getting, and neither would the study team, to keep the results fair. Both would be given as a single dose.

During your time in the study, you would have regular visits to the hospital or clinic. These visits would involve health checks, blood tests, and possibly other tests to see how your body is reacting to the medicine and to monitor for any side effects. The total duration of your participation would depend on the study design, but generally, early-phase studies like this involve close monitoring for a set period after the dose is given, followed by follow-up checks.

Potential risks and benefits

Participating in a study like this means you would be among the first people to try a new medicine, which could potentially help advance medical knowledge for a serious condition. However, there's also the risk of side effects from the experimental medicine, some of which might not be known yet. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is sepsis-associated disseminated intravascular coagulation (DIC)?

It's a serious condition where an overwhelming infection (sepsis) causes widespread problems with blood clotting and bleeding throughout the body.

What is a 'first-in-human' study?

This means it's the very first time this new medicine is being given to people. It's a key early step to check its safety and how the body handles it.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers compare the new medicine's effects fairly.

Will I know if I'm getting the new medicine or the placebo?

No, during the study, neither you nor the doctors will know who is receiving the new medicine and who is receiving the placebo. This helps keep the study fair and unbiased.

Will this medicine cure my condition?

The main goal of this early study is to check for safety and how the body reacts to the medicine, not to confirm a cure. It's an important step towards future potential treatments.