Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers

Recruitment & Eligibility

Inclusion Criteria

All participants are healthy males
Age range from 21 to 50 years
Broca-Index: within +- 20% of their normal weight
In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

Exclusion Criteria

Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
Volunteers with history of orthostatic hypotension, fainting spells or blackouts
Volunteers with chronic or relevant acute infections
Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Volunteers with eosinophilia > 7 %
Volunteers who have taken a drug with a long half-life (>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment in the study
Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
Volunteers who smoke
Volunteers who drink more than 60g of alcohol per day
Volunteers who are dependent on drugs
Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Volunteers who have donated blood within the last 4 weeks (>= 100 mL)

Study & Design

Arm && Interventions

Group	Intervention	Description
BIIL 284 BS - rising dose	BIIL 284 BS - rising dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters	up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs	up to 8 days after last drug administration	Blood pressure, Pulse Rate, Respiratory Rate
Number of subjects with clinically significant changes in 12-lead electrocardiogram	up to 8 days after last drug administration

Secondary Outcome Measures

Name	Time	Method
tmax (Time from dosing to the maximum concentration of the analyte in plasma)	up to 80 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)	up to 80 hours after drug administration
Changes in Leucotriene B4 (LTB4) induced Mac-1 expression	up to 24 hours after last treatment on day 9
AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)	up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)	up to 80 hours after drug administration
MRTtot (Total mean residence time)	up to 80 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)	up to 80 hours after drug administration
CLtot/F (Total clearance after oral administration)	up to 80 hours after drug administration
Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)	up to 24 hours after drug administration
AUCss (Area under the plasma concentration-time curve at steady state)	up to 80 hours after drug administration
Cpre,ss (Predose concentration of the analyte in plasma at steady state)	up to 80 hours after drug administration

Recruitment & Eligibility