A Phase 1 interventional study of BAY3018250 Dose 1 and Placebo in Acute Venous and Arterial Thrombotic and Thromboembolic Events and Healthy Volunteers, sponsored by Bayer. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Bayer · Phase 1, Interventional, and Other
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:
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 of the study. Participants will be randomly assigned to receive a certain dose of BAY3018250 or placebo by an injection once during the study.
Each participant will be in the study for around 14 weeks, which includes:
818 studies on the registry are indexed under Thromboembolism; 95 are open to participants now.
This study's enrollment of 39 is below the median of 194 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion:
Part A:
Part B:
Exclusion Criteria:
Participants will receive a single dose of BAY3018250 dose step 1 via infusion in part A.
Drug: BAY3018250 Dose 1
Participants will receive a single dose of BAY3018250 dose step 2 via infusion in part A.
Drug: BAY3018250 Dose 2 infusion
Participants will receive a single dose of BAY3018250 matching placebo via infusion in part A.
Drug: Placebo
Participants will receive a single dose of BAY3018250 dose step 2 via injection in part B.
Drug: BAY3018250 Dose 2 injection
Participants will receive a single dose of BAY3018250 matching placebo via injection in part B.
Drug: Placebo
Infusion, single dose
BAY3018250 matching placebo, infusion
BAY3018250 matching placebo, injection
Infusion, single dose
Injection, single dose
Number of participants who experienced treatment-emergent adverse events (TEAEs) after administration of BAY3018250
Time frame: Administration of study intervention until last follow-up visit (75 days)
Cmax of BAY3018250
Time frame: Administration of study intervention until Day 75
AUC of BAY3018250
If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead.
Time frame: Administration of study intervention until Day 75
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Inclocibart