Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
Study NCT ID:
NCT06125366
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-11-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn More About the Safety and the Level of BAY 1747846 in Body Given as Injection Into the Vein at Increasing Single Doses in Japanese Healthy Male Participants
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Japanese Healthy Male Subjects
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 Japanese healthy male participants:
* the safety of BAY1747846 when given at increasing single doses
* the level of BAY1747846 in the body over time when given at increasing single doses.
To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do 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 body, also called AUC
* the (average) highest level of BAY1747846 in the body, also called Cmax
* how BAY1747846 is removed from the body, also called clearance (CL).
* the safety of BAY1747846 when given at increasing single doses
* the level of BAY1747846 in the body over time when given at increasing single doses.
To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do 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 body, also called AUC
* the (average) highest level of BAY1747846 in the body, also called Cmax
* how BAY1747846 is removed from the body, also called clearance (CL).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: