A Study to Learn How Safe the Study Treatment BAY2701250 is, How it Affects the Body and How it Moves Into, Through and Out of the Body in Healthy Male Participants When a Single Amount is Given as an Injection Into the Vein (Intravenous Infusion) or Under the Skin (Subcutaneous Injection)

Summary

Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by diseases in the left side of the heart.

The study treatment, BAY2701250 is under development and will be tested in humans for the first time in this study. Once it is approved, it may help treat people with PH due to left heart disease.

The participants of this study will be healthy and will have no benefit from the administration of BAY2701250. However, the study will provide important information for the design of subsequent studies with BAY2701250 in people with PH due to left heart disease. The participants will be randomly (by chance) assigned to receive either placebo or BAY2701250 as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection). A placebo is a treatment that looks like a medicine but does not have any medicine in it.

The main purpose of this first in human study is to learn how safe is BAY2701250 and to what degree medical problems caused by it can be tolerated by the study participants after they receive a single amount (dose) either as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection)?

To answer this, the researchers will collect the number of study participants with medical problems (also called adverse events) after receiving BAY2701250 until the end of the study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatment.

Further objectives of this study are to learn how does a single dose of BAY2701250 move into, through and out the body of the participants after an intravenous infusion or a subcutaneous injection?

To answer this, the researchers will measure:

* The (average) total level of BAY2701250 in the blood (also called AUC)
* AUC divided by dose (also called AUC/D)
* The (average) highest level of BAY2701250 in the blood (also called Cmax)
* Cmax divided by dose (Cmax/D) after receiving either an intravenous infusion or subcutaneous injection of BAY2701250.

A group of participants will start out by receiving a low dose of BAY2701250. The study doctors will look at the results from these participants and then decide whether to increase the dose of BAY2701250 in the next group of participants.

Each participant will be in the study for approximately 9-10 weeks, including a first test (screening) phase, an in-house stay of a maximum of 14 days and a follow-up phase after the end of treatment.

One visit to the study site is planned during the screening phase, followed by 6 visits (two of which are optional) after the end of treatment.

During the study, the study team will, among other:

* take blood and urine samples
* do physical examinations
* examine heart health using electrocardiogram (ECG) and
* check vital signs such as blood pressure, heart rate and body temperature

Conditions

• Pulmonary Hypertension Due to Left Heart Disease

Interventions

DRUG

BAY2701250 IV

Single does, intravenous infusion

DRUG

Placebo IV

Matching placebo for BAY2701250 IV

DRUG

BAY2701250 SC

Single dose, subcutaneous injection will be administered into abdominal subcutaneous fat tissue

DRUG

Placebo SC

Matching placebo for BAY2701250 SC

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-15

Primary Completion

2025-05-20

Completion

2025-05-20

Countries

• Germany

Study Locations