NCT06135181

A Study to Learn More About the Safety and the Blood Level of BAY1747846 Given as Injection Into the Vein at Increasing Single Doses in Chinese Healthy Male Participants

Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study of Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 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 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).

Conditions

• Contrast Enhancement in Magnetic Resonance Imaging
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg	0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)
DRUG	Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg	0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)
DRUG	Matching placebo	0.9% sodium chloride by intravenous injection (at 2 mL/s)

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-02-02
• Completion: 2021-04-30
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: China