BridgeMD
A first-in-human study to learn how safe the study treatment BAY3018250 is, how it affects the body, how it moves into, through, and out of the body, and what it does in healthy men when given in single, increasing doses compared to placebo
EU CTIS ID: 2022-500505-41-00
What this study is testing
Investigate the safety and tolerability of BAY 3018250 after single doses of 150 mg up to 1200 mg, administered as intravenous infusion in healthy male participants.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men must be 18 to 45 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 signand 12-lead electrocardiogram (ECG)
- Body weight equal or above 65 kg and body mass index above or equal 18.0 to below or equal to 29.9 kg/m2 (inclusive) at screening
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
You likely can't join if
- Medical disorder, condition 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
- Clinically relevant findings in the physical examination
- Diseases for which it can be assumed that effects of the study intervention(s) will not be normal
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g. non-investigational medicinal products, challenge agents, or rescue medication
- Known severe allergies, e.g. allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions
- Participants with tendency to the develop Keloid or major scars after injuries
See the full eligibility criteria
- Men must be 18 to 45 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 signand 12-lead electrocardiogram (ECG)
- Body weight equal or above 65 kg and body mass index above or equal 18.0 to below or equal to 29.9 kg/m2 (inclusive) at screening
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Medical disorder, condition 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
- Clinically relevant findings in the physical examination
- Diseases for which it can be assumed that effects of the study intervention(s) will not be normal
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g. non-investigational medicinal products, challenge agents, or rescue medication
- Known severe allergies, e.g. allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions
- Participants with tendency to the develop Keloid or major scars after injuries
- Known coagulation disorders (e.g., von Willebrand´s disease, hemophilia)
- Known disorders with increased bleeding risk (e.g., periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer etc.)
- Known sensitivity to common causes of bleeding (e.g., nasal, etc.)
- History of hemorrhage and gastro-intestinal ulceration within 6 month prior to the screening visit
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.