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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
25
Single dose; IV injection.
Single dose; IV injection.
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Japan
Number of participants with treatment-emergent adverse events
Time frame: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
Severity of treatment-emergent adverse events
Time frame: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug (CL)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug normalized by body weight (CL/bw)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
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