Healthy
Conditions
Brief summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.
Interventions
BIOLOGICALBI 3814916
BI 3814916
DRUGPlacebo matching BI 3814916
Placebo matching BI 3814916
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Part A: Single rising dose (SRD) Part B: Multiple rising dose (MRD)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age of 18 to 65 years (inclusive) at the time of screening 2. Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening 3. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 4. Agree to refrain from strenuous or unusual exercise/activity (for example heavy lifting, weight training, intense aerobics classes, etc.) for at least 72 hours prior to study visits. 5. Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits. Further inclusion criteria apply.
Exclusion criteria
1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator | up to 111 days |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 72 days |
| Part A: Maximum measured concentration of the analyte in serum (Cmax) | up to 72 days |
| Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed | up to 108 days |
| Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed | up to 108 days |
Countries
Belgium
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed