NCT06619483

A Study to Learn How Safe BAY3018250 is, How it Moves Into, Through and Out of the Body, and How it Affects the Body in Healthy Chinese Participants

Completed Phase 1 Last updated 10 February 2025

What this trial tests

Phase 1 trial testing BAY3018250 Dose 1 in Acute Venous and Arterial Thrombotic and Thromboembolic Events in 24 participants. Completed in 24 January 2025.

Timeline

10 October 2024

Primary endpoint
24 January 2025

24 January 2025

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	24
Start date	10 October 2024
Primary completion	24 January 2025
Estimated completion	24 January 2025
Sites	1 location across China

Drugs / interventions tested

• BAY3018250 Dose 1 — full drug profile →
• Placebo
• BAY3018250 Dose 2

Conditions studied

• Acute Venous and Arterial Thrombotic and Thromboembolic Events — all drugs for Acute Venous and Arterial Thrombotic and Thromboembolic Events →
• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, any sex, with Acute Venous and Arterial Thrombotic and Thromboembolic Events or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events.

Acute venous and arterial thrombotic and thromboembolic events refer to blood clots that form and cause blockages in blood vessels that may cause serious complications.

The study treatment BAY3018250 is under development to treat acute venous and arterial thrombotic and thromboembolic events. It works by dissolving blood clots.

In this study, participants will be healthy and will not benefit from BAY3018250. However, the study will provide information about how to test BAY3018250 in future studies of people with acute venous and arterial thrombotic and thromboembolic events.

The results of this study will help in the future development of BAY3018250 as a treatment option for participants with acute venous and arterial thrombotic and thromboembolic events. It will also help in learning more about the drug when given to Chinese participants and helps in involving Chinese sites in clinical trials, to obtain approval for BAY3018250 in China.

The main purpose of this study is to check if BAY3018250 is safe for further testing.

For this, researchers will study the number and severity of medical problems participants have after receiving different amounts of BAY3018250. 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 treatment.

In this study, there will be two groups. In each group, participants will be randomly assigned to receive a single dose of either BAY3018250 or placebo as an infusion into a vein, on Day 1. A placebo looks like a study drug but does not have any medicine in it.

In the first group, participants will receive a low dose of BAY3018250. If researchers consider this dose to be safe, the next group will receive a higher dose.

Each participant will be in the study for around 14 weeks, which includes:

a visit to the clinic within 21 days before taking any treatment to confirm if the participant can take part in the study

a hospital stay for around 7 days, during which participants will take their assigned treatment and have blood samples taken to check for drug levels

five follow-ups on Day 10, Day 14, Day 28, Day 42, and Day 75. The last follow-up might be done by phone

During the study, the doctors and their study team will:

collect blood samples from the participants to measure the levels of the study drug given

check participants' health by performing blood and urine tests, measuring the blood pressure, pulse rate and body temperature, and checking heart health using an electrocardiogram (ECG)

ask the participants questions about how they are feeling and what adverse events they are having

As this study is conducted in healthy participants who will not benefit from the treatment, access to the treatment after the study is not planned.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.