A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BI 3814916, Placebo matching BI 3814916.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BI 3814916 in Healthy Male and Female Subjects
Overview
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
- Biological BI 3814916
BI 3814916 - Drug Placebo matching BI 3814916
Placebo matching BI 3814916
Primary outcome measures
- Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator [Time frame: up to 111 days]
Secondary outcome measures (4)
- Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) [Time frame: up to 72 days]
- Part A: Maximum measured concentration of the analyte in serum (Cmax) [Time frame: 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 [Time frame: 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 [Time frame: up to 108 days]
Eligibility criteria
Inclusion criteria
- Age of 18 to 65 years (inclusive) at the time of screening
- Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
- 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
- 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.
- 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
- 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
- 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)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- SGS Life Science Services - Clinical Research — Edegem
Identifiers
NCT: NCT07486115 · 1543-0001 · 2025-523262-25-00 · 1111-1325-7389