Acute Venous and Arterial Thrombotic and Thromboembolic EventsPhase 1NCT06562985
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 testing BAY3018250 Dose 1, BAY3018250 Dose 2 infusion and BAY3018250 Dose 2 injection in people with Acute Venous and Arterial Thrombotic and Thromboembolic Events and Healthy Volunteers, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Venous and Arterial Thrombotic and Thromboembolic Events, Healthy Volunteers
- What is being tested?
- BAY3018250 Dose 1, BAY3018250 Dose 2 infusion and BAY3018250 Dose 2 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 6 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and electrocardiogram (ECG).
- Japanese who was born in Japan and whose parents and grandparents must have been Japanese and who has not lived outside of Japan for more than 10 years and has not significantly modified their diets since leaving Japan.
- Male
- Part B:
Show all 9Show fewer
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and ECG.
- Male or female (postmenopausal or hysterectomized only)
Who cannot join
- Medical disorder, condition (e.g., after surgical procedure), or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
- Increased bleeding risk: known coagulation disorders (e.g., von Willebrand´s disease, hemophilia), periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, or similar diseases with tendency to lead to bleedings, known sensitivity to common causes of bleeding (e.g., nasal, etc.), or history of hemorrhage and gastrointestinal ulceration within 6 months prior to the screening visit.
- Family history of hereditary or not explainable bleeding disorders.
- History of thrombosis or family history of hereditary or not explainable diseases with increased risk for thrombosis or thromboembolic events.
- Tendency of easy bruising.
- Platelets out of reference range.
- Activated partial thromboplastin time (aPTT) or prothrombin time (PT) out of reference range.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
About this study
Official title: A Single Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 3018250 After Intravenous Infusion in Healthy Male Japanese Participants in a Dose Escalation Design and a Single Intravenous Bolus Injection in Healthy Adult Participants
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.
Read more
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 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:
- a visit to the hospital within 3 weeks of taking any treatment to confirm if the participant can take part in the study
- a hospital stay of 1 week, during which participants will receive their assigned treatment, have blood and urine tests and complete health check-ups
- six follow-up visits to the hospital until about 11 weeks after receiving the study treatments During the study, the doctors and their study team will check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) 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.
- Being tested
- BAY3018250 Dose 1, Placebo, BAY3018250 Dose 2 infusion, BAY3018250 Dose 2 injection
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3018250 Dose 1Drug
Infusion, single dose
PlaceboDrug
BAY3018250 matching placebo, infusion
PlaceboDrug
BAY3018250 matching placebo, injection
BAY3018250 Dose 2 infusionDrug
Infusion, single dose
BAY3018250 Dose 2 injectionDrug
Injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Dose step 1 (Part A) | Experimental | Participants will receive a single dose of BAY3018250 dose step 1 via infusion in part A. Receives: Drug: BAY3018250 Dose 1 |
| Dose step 2 (Part A) | Experimental | Participants will receive a single dose of BAY3018250 dose step 2 via infusion in part A. Receives: Drug: BAY3018250 Dose 2 infusion |
| Placebo (Part A) | Placebo comparator | Participants will receive a single dose of BAY3018250 matching placebo via infusion in part A. Receives: Drug: Placebo |
| Dose step 2 (Part B) | Experimental | Participants will receive a single dose of BAY3018250 dose step 2 via injection in part B. Receives: Drug: BAY3018250 Dose 2 injection |
| Placebo (Part B) | Placebo comparator | Participants will receive a single dose of BAY3018250 matching placebo via injection in part B. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced treatment-emergent adverse events (TEAEs) after administration of BAY3018250
Measured: Administration of study intervention until last follow-up visit (75 days)
Secondary outcomes (2)
Cmax of BAY3018250
Measured: 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.
Measured: Administration of study intervention until Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Sep 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Venous and Arterial Thrombotic and Thromboembolic EventsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562985
- Sponsor's protocol ID
- 22497
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 3018250 After Intravenous Infusion in Healthy Male Japanese Participants in a Dose Escalation Design and a Single Intravenous Bolus Injection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06562985
- Acronym / sponsor ID
- 22497
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- a visit to the hospital within 3 weeks of taking any treatment to confirm if the participant can take part in the study
- a hospital stay of 1 week, during which participants will receive their assigned treatment, have blood and urine tests and complete health check-ups
- six follow-up visits to the hospital until about 11 weeks after receiving the study treatments During the study, the doctors and their study team will check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose step 1 (Part A) | Experimental | Drug: BAY3018250 Dose 1Participants will receive a single dose of BAY3018250 dose step 1 via infusion in part A. |
| Dose step 2 (Part A) | Experimental | Drug: BAY3018250 Dose 2 infusionParticipants will receive a single dose of BAY3018250 dose step 2 via infusion in part A. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of BAY3018250 matching placebo via infusion in part A. |
| Dose step 2 (Part B) | Experimental | Drug: BAY3018250 Dose 2 injectionParticipants will receive a single dose of BAY3018250 dose step 2 via injection in part B. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of BAY3018250 matching placebo via injection in part B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and electrocardiogram (ECG).
- Japanese who was born in Japan and whose parents and grandparents must have been Japanese and who has not lived outside of Japan for more than 10 years and has not significantly modified their diets since leaving Japan.
- Male
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Key exclusion criteria (7 listed)
- Medical disorder, condition (e.g., after surgical procedure), or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
- Increased bleeding risk: known coagulation disorders (e.g., von Willebrand´s disease, hemophilia), periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, or similar diseases with tendency to lead to bleedings, known sensitivity to common causes of bleeding (e.g., nasal, etc.), or history of hemorrhage and gastrointestinal ulceration within 6 months prior to the screening visit.
- Family history of hereditary or not explainable bleeding disorders.
- History of thrombosis or family history of hereditary or not explainable diseases with increased risk for thrombosis or thromboembolic events.
- Tendency of easy bruising.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY3018250 Dose 1Infusion, single dose | Drug | Dose step 1 (Part A) |
| PlaceboBAY3018250 matching placebo, infusion | Drug | Placebo (Part A) |
| PlaceboBAY3018250 matching placebo, injection | Drug | Placebo (Part B) |
| BAY3018250 Dose 2 infusionInfusion, single dose | Drug | Dose step 2 (Part A) |
| BAY3018250 Dose 2 injectionInjection, single dose | Drug | Dose step 2 (Part B) |
Primary outcome
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)
2 secondary outcomes
Cmax of BAY3018250
Time frame: Administration of study intervention until Day 75
AUC of BAY3018250
Time frame: Administration of study intervention until Day 75
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3018250 Dose 1, BAY3018250 Dose 2 infusion and BAY3018250 Dose 2 injection in people with Acute Venous and Arterial Thrombotic and Thromboembolic Events and Healthy Volunteers, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.