Beijing Hospital
Beijing, 100730, China
NCT Number: NCT06135181
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).
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Beijing, 100730, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)
0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)
0.9% sodium chloride by intravenous injection (at 2 mL/s)
Time frame: From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)
Including severity of TEAE
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4
AUC: Area under the concentration vs. time curve from zero to infinity after single dose in case AUC cannot be determined reliably for all participants, AUC will be replaced by AUC(0-tlast)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4
CL: Total body clearance of drug
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
CL/bw: Total body clearance of drug normalized by body weight
Bayer
Industry
Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study of Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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