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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Male, white participants aged 18 to 45 years
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
Body weight ≥ 70 kg and ≤ 100 kg as well as body mass index (BMI) within the range of 18.0 to 29.9 kg/m\^2 (inclusive)
The informed consent must be signed before any study specific tests or procedures are done
Ability to understand and follow study-related instructions
You may not be if
Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator
Thyroid disorders as evidenced by assessment of thyroid-stimulating hormone levels outside the normal reference range and confirmed by triiodothyronine and thyroxine at screening
Known hypersensitivity to the study interventions (active substances or excipients of the preparations)
Relevant diseases within the last 4 weeks prior to the administration of study intervention
Febrile illness within 1 week before the administration of study intervention
Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope
Regular use of medicines
Use of any drug within 14 days before the administration of study intervention, except single doses of paracetamol, ibuprofen or topical medicines
Previous (within 90 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s)
Clinically relevant findings in the physical examination
Clinically relevant findings in the electrocardiogram (ECG)
Systolic BP below 100 or above 140 mmHg at screening for all cohorts except for the additional optional Dose Step 8 (Cohort 8) for which systolic BP below 110 or above 140 mmHg at screening will be applicable
Diastolic blood pressure (BP) below 60 or above 90 mmHg at screening
Pulse rate below 50 or above 90 beats per minute at screening
Positive urine drug screening
Positive alcohol breath test
Positive results for human immunodeficiency virus (HIV) antibodies (anti-HIV 1+2), or HIVp24 antigen
Positive results for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV)
Clinically relevant deviations of the screened safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges at screening
Smoking
Regular daily consumption of more than 1 L of methylxanthine-containing beverages
Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
Unable/unwilling to comply with study restrictions
Clareo Health | 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)
