Phase 1
Completed N=40
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT02852824 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events (AEs). — 50.0; 16.7; 66.7; 33.3 Percentage of participants
Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events (AEs). |
50.0; 16.7; 66.7; 33.3; 100.0; 0.0 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
10500 | — |
| SECONDARY Maximum Measured Concentration of the BI 655130 in Plasma (Cmax) |
77.90; 130.00; 229.00; 422.00; 490.00 | — |
| SECONDARY Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4) |
141.00; 253.00; 467.00; 826.00 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1) |
298.00; 552.00; 923.00; 1770.00 | — |
| SECONDARY Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4) |
760.00; 1390.00; 2500.00; 4660.00 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria
- Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02852824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.