Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562985
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None