drugset / Trial / 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

NCT06125366

Phase 1 Completed 25 enrolled Bayer
RandomizedSequentialSingle-blindOther

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).

Timeline

Start
2019-04-17
Primary completion
2019-06-19
Completion
2019-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadoquatrane Diagnostic / imaging agent Intravenous

Indications

No indication recorded.