Clinical trial NCT06081530: A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated
Official title: Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of ≥18 to ≤55 years at screening
3. Body mass index (BMI) of ≥ 19.0 to ≤ 28.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
4. Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Three repeated measurements of systolic BP outside the range of 80 to 130 mm Hg, diastolic BP outside the range of 50 to 80 millimetre of mercury (mmHg), or pulse outside the range of 45 to 90 beats per minute.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Further exclusion criteria apply

Primary outcomes:
measure: Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)
timeFrame: up to Day 35 for Part A and up to Day 117 for Part B
Secondary outcomes:
measure: Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to Day 35
measure: Part A: Maximum measured concentration of the analyte in serum (Cmax)
timeFrame: up to Day 35
measure: Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state, if steady state can be reasonably assumed (AUCτ,ss)
timeFrame: up to Day 117
measure: Part B: Maximum measured concentration of the analyte in serum at steady state, if steady state can be reasonably assumed (Cmax,ss)
timeFrame: up to Day 117
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References: