Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

Single-blind, Partially Randomised, Placebo-controlled Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous Doses of BI 655130 in Healthy Male Volunteers

The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 655130 (spesolimab)

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2060
    • SGS Life Science Services - Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Puls Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
• Age of 18 to 45 years (incl.)
• BMI (Body Mass Index) 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
• Cholecystectomy and/or surgery of the gastrointestinal tract (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BI 655130 (spesolimab)	Drug: BI 655130 (spesolimab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Drug Related Adverse Events	Percentage of subjects with drug related adverse events are presented.	Adverse events reported until the end-of-trial examination; up to day 74

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	Maximum measured concentration of BI 655130 in plasma (Cmax) is presented.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz)	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2015
• Primary Completion (Actual): May 27, 2016
• Study Completion (Actual): May 27, 2016

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimated): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1368.1; 2015-001931-19 (EudraCT Number: EudraCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No