Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135181
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-13
Brief Title:
A Study to Learn More About the Safety and the Blood Level of BAY1747846 Given as Injection Into the Vein at Increasing Single Doses in Chinese Healthy Male Participants
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Randomized Single-blind Placebo-controlled Escalating Single-dose Study of Safety Tolerability and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants
the safety of BAY1747846 when given at increasing single doses
the level of BAY1747846 in the blood over time when given at increasing single doses
To answer the first question the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively Doctors kept tracking of all medical problems that happened in the study even if they did not think they might be related to the study treatments
To answer the second question the researchers determined
the average total level of BAY1747846 in the blood also called AUC
the average highest level of BAY1747846 in the blood also called Cmax
how BAY1747846 is removed from the blood also called clearance CL
the safety of BAY1747846 when given at increasing single doses
the level of BAY1747846 in the blood over time when given at increasing single doses
To answer the first question the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively Doctors kept tracking of all medical problems that happened in the study even if they did not think they might be related to the study treatments
To answer the second question the researchers determined
the average total level of BAY1747846 in the blood also called AUC
the average highest level of BAY1747846 in the blood also called Cmax
how BAY1747846 is removed from the blood also called clearance CL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None