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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-11-09

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 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).

Conditions

  • Contrast Enhancement in Magnetic Resonance Imaging
  • Healthy Volunteers

Interventions

DRUG

BAY1747846

Single dose; IV injection.

DRUG

Matching placebo

Single dose; IV injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Japan

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 NCT06125366 on ClinicalTrials.gov