Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06048120
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06048120
Study Brief:
Protocol Section:
NCT06048120