NCT06125366

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Contrast Enhancement in Magnetic Resonance Imaging
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BAY1747846	Single dose; IV injection.
DRUG	Matching placebo	Single dose; IV injection.

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-06-19
• Completion: 2019-07-11
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: Japan