Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619483
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_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
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
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
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