Acute Venous and Arterial Thrombotic and Thromboembolic EventsPhase 1NCT06619483
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
A Phase 1 study testing BAY3018250 Dose 1 and BAY3018250 Dose 2 in people with Acute Venous and Arterial Thrombotic and Thromboembolic Events and Healthy Volunteers, run by Bayer at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy 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 and BAY3018250 Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 24 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age (both inclusive) at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test and 12-lead Electrocardiogram (ECG).
- Race: Chinese
- Body mass index (BMI) within the range above or equal to 18.0 to below or equal to 27.9 kg/m*2 at screening.
- Body weight equal or above 55 kg
- Male or postmenopausal or hysterectomized female participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent
Who cannot join
- 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 sudden death of unknown reason.
- 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.
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them, e.g. acetylic salicylic acid, heparin, or other Nonsteroidal anti-inflammatory drugs (NSAIDS) or anti-coagulant within 2 weeks or 5 half-lives (whichever is longer) prior to study drug administration or intended during the study.
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- Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study intervention administration.
- Platelets out of reference range.
- Activated partial thromboplastin time (aPTT) or prothrombin time (PT) above the upper normal or below 0.5-fold of the lower normal reference range.
- Positive fecal occult blood test.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
About this study
Official title: A Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 3018250 in Chinese Healthy Participants
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.
Read more
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.
- Being tested
- BAY3018250 Dose 1, Placebo, BAY3018250 Dose 2
- 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
Single dose
PlaceboDrug
Matching placebo to BAY3018250
BAY3018250 Dose 2Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| BAY3018250 Dose 1 | Experimental | Participants will receive BAY3018250 Dose 1. Receives: Drug: BAY3018250 Dose 1 |
| BAY3018250 Dose 2 | Experimental | Participants will receive BAY3018250 Dose 2. Receives: Drug: BAY3018250 Dose 2 |
| Placebo | Placebo comparator | Participants will receive the matching placebo to BAY3018250. 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) and drug-related TEAEs after administration of BAY3018250
Measured: Administration of study intervention until last follow-up visit (approximately 75 days)
Secondary outcomes (2)
Maximum Concentration (Cmax) of BAY3018250
Measured: Pre-dose until Day 42
Area Under the Curve (AUC) of BAY3018250
If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead.
Measured: Pre-dose until Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024
- Primary completion24 Jan 2025
- Study completion24 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619483
- Sponsor's protocol ID
- 22491
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY 3018250 in Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT06619483
- Acronym / sponsor ID
- 22491
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 1 Oct 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAY3018250 Dose 1 | Experimental | Drug: BAY3018250 Dose 1Participants will receive BAY3018250 Dose 1. |
| BAY3018250 Dose 2 | Experimental | Drug: BAY3018250 Dose 2Participants will receive BAY3018250 Dose 2. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive the matching placebo to BAY3018250. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 18 to 55 years of age (both inclusive) at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test and 12-lead Electrocardiogram (ECG).
- Race: Chinese
- Body mass index (BMI) within the range above or equal to 18.0 to below or equal to 27.9 kg/m*2 at screening.
- Body weight equal or above 55 kg
Key exclusion criteria (10 listed)
- 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 sudden death of unknown reason.
- 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 1Single dose | Drug | BAY3018250 Dose 1 |
| PlaceboMatching placebo to BAY3018250 | Drug | Placebo |
| BAY3018250 Dose 2Single dose | Drug | BAY3018250 Dose 2 |
Primary outcome
Number of participants who experienced treatment-emergent adverse events (TEAEs) and drug-related TEAEs after administration of BAY3018250
Time frame: Administration of study intervention until last follow-up visit (approximately 75 days)
2 secondary outcomes
Maximum Concentration (Cmax) of BAY3018250
Time frame: Pre-dose until Day 42
Area Under the Curve (AUC) of BAY3018250
Time frame: Pre-dose until Day 42
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 10 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 and BAY3018250 Dose 2 in people with Acute Venous and Arterial Thrombotic and Thromboembolic Events and Healthy Volunteers, run by Bayer at 1 site in China.
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 7 inclusion and 10 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 10 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 China. 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) and drug-related TEAEs after administration of BAY3018250 (time frame: Administration of study intervention until last follow-up visit (approximately 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 10 Feb 2025.