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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

NCT06135181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-18

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2021-02-02
Completion
2021-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135181 on ClinicalTrials.gov