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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 655130 (spesolimab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525679

2015-001931-19 (EudraCT Number)

1368.1

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups, including a placebo group

BI 655130 (spesolimab)

Experimental group

Treatment:

Drug: BI 655130 (spesolimab)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo