Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Placebo
Drug: BIIL 284 BS - rising dose
Details and patient eligibility
About
The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
Enrollment
35 patients
Sex
Male
Ages
21 to 50 years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
35 participants in 2 patient groups, including a placebo group
BIIL 284 BS - rising dose
Experimental group
Treatment:
Drug: BIIL 284 BS - rising dose
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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