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NCT06562985 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 Years
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT06562985 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 39 participants.
The verdict
NCT06562985, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels. The study treatment BAY3018250 is under development to treat acute venous and arterial thrombotic and thromboembolic events. It aims to work by dissolving blood clots in the blood vessels. In this study, participants will be healthy and will not benefit from receiving BAY3018250. However, the study will provide information on how to test BAY3018250 in future studies in people with acute venous and arterial thrombotic and thromboembolic events. During the study, researchers will use two different methods of giving BAY3018250 to participants. This may help in developing a faster method of giving this treatment in case of emergencies. The main purpose of this study is to check how safe BAY3018250 is and if it is well tolerated by participants. For this, researchers will study the number and severity of medical problems in: * healthy Japanese men after receiving different doses of BAY3018250 as an infusion into a vein. * healthy adult participants after receiving a certain dose of BAY3018250 by an injection. 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. This study will have two parts: Part A and Part B: \- Only healthy Japanese men can join Part A of the study, which will have two groups. 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. In each group, participants will be randomly assigned to receive BAY3018250 or placebo as an infusion into a vein once during the study. A placebo looks like a study drug but does not have any medicine in it. \- Healthy men and women can join Part B o
Interventions
- DRUG Placebo
- DRUG BAY3018250 Dose 1
- DRUG BAY3018250 Dose 2 infusion
- DRUG BAY3018250 Dose 2 injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2025-01-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06562985
The ClinicalTrials.gov registry entry for NCT06562985 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT06562985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06562985 about?
NCT06562985 is a clinical study titled "A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 Years". Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels. The study treatment BAY3018250 is under development to treat acute venous and...
What is the current status of trial NCT06562985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2024-09-18. Estimated completion is 2025-01-06.
What interventions are being tested in trial NCT06562985?
The interventions under investigation include: Placebo (DRUG), BAY3018250 Dose 1 (DRUG), BAY3018250 Dose 2 infusion (DRUG), BAY3018250 Dose 2 injection (DRUG).
Who is sponsoring clinical trial NCT06562985?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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