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BAY3018250 Dose 1

Phase 1

Acute Venous and Arterial Thrombotic and Thromboembolic Events | Small molecule | Other |Bayer AG|Last Updated: Feb 10, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials2
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

BAY3018250 Dose 1 · 2 trials · 2 indications

Phase 1 2
NCT06619483A 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 ParticipantsAcute Venous and Arterial Thrombotic and Thromboembolic Events
COMPLETED24 Analytics
NCT06562985A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 YearsAcute Venous and Arterial Thrombotic and Thromboembolic Events
COMPLETED39 Analytics
PHASE1COMPLETED
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
Acute Venous and Arterial Thrombotic and Thromboembolic Events
NCT0661948324
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PHASE1COMPLETED
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
Acute Venous and Arterial Thrombotic and Thromboembolic Events
NCT0656298539
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Study Endpoints

Primary Endpoints

Number of participants who experienced treatment-emergent adverse events (TEAEs) and drug-related TEAEs after administration of BAY3018250
Administration of study intervention until last follow-up visit (approximately 75 days)
Number of participants who experienced treatment-emergent adverse events (TEAEs) after administration of BAY3018250
Administration of study intervention until last follow-up visit (75 days)

Secondary Endpoints

Maximum Concentration (Cmax) of BAY3018250
Pre-dose until Day 42
Area Under the Curve (AUC) of BAY3018250
Pre-dose until Day 42
Cmax of BAY3018250
Administration of study intervention until Day 75
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
BAY3018250 Dose 1EXPERIMENTALParticipants will receive BAY3018250 Dose 1.
BAY3018250 Dose 2EXPERIMENTALParticipants will receive BAY3018250 Dose 2.
PlaceboPLACEBO_COMPARATORParticipants will receive the matching placebo to BAY3018250.
Dose step 1 (Part A)EXPERIMENTALParticipants will receive a single dose of BAY3018250 dose step 1 via infusion in part A.
Dose step 2 (Part A)EXPERIMENTALParticipants will receive a single dose of BAY3018250 dose step 2 via infusion in part A.
Placebo (Part A)PLACEBO_COMPARATORParticipants will receive a single dose of BAY3018250 matching placebo via infusion in part A.
Dose step 2 (Part B)EXPERIMENTALParticipants will receive a single dose of BAY3018250 dose step 2 via injection in part B.
Placebo (Part B)PLACEBO_COMPARATORParticipants will receive a single dose of BAY3018250 matching placebo via injection in part B.

Interventions

NameTypeDescription
BAY3018250 Dose 1DRUGSingle dose
PlaceboDRUGMatching placebo to BAY3018250
BAY3018250 Dose 2DRUGSingle dose
BAY3018250 Dose 2 infusionDRUGInfusion, single dose
BAY3018250 Dose 2 injectionDRUGInjection, single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 (EC...

Countries:ChinaUnited States
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Frequently asked questions about BAY3018250 Dose 1

What is BAY3018250 used for?

BAY3018250 is an investigational small molecule being developed for thrombolysis and for acute venous and arterial thrombotic and thromboembolic events. It has been studied in patients with symptomatic proximal deep vein thrombosis and in healthy volunteers. The drug is currently in Phase 2 clinical development.

What does BAY3018250 target?

BAY3018250 is a small molecule designed for thrombolysis, meaning it is intended to break down blood clots. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its ability to treat acute venous and arterial thrombotic and thromboembolic events.

Who makes BAY3018250?

BAY3018250 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for thrombolysis and thrombotic conditions.

What phase is BAY3018250 in?

BAY3018250 is in Phase 2 clinical development. It has completed a Phase 2 trial in patients with proximal deep vein thrombosis and two Phase 1 trials in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BAY3018250 in?

BAY3018250 has completed three clinical trials. NCT06149520 was a Phase 2 study in 283 patients with symptomatic proximal deep vein thrombosis. NCT06562985 was a Phase 1 study in 39 healthy Japanese men, and NCT06619483 was a Phase 1 study in 24 healthy Chinese participants.

Is BAY3018250 the same as any other drug?

No alternative names for BAY3018250 have been disclosed. The drug is identified solely by its code name BAY3018250 in clinical trial registries and available information. It is an investigational small molecule being developed by Bayer AG.