Healthy
Conditions
Brief summary
The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.
Interventions
DRUGAbGn-168H
single very low dose of AbGn-168H i.v.
DRUGPlacebo
single dose of Placebo i.v.
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males according to following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests 2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 3. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease in the opinion of the investigator 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders 4. Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months 5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 6. Use of biologic agents within 12 weeks prior to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| MRT sc (mean residence time of the analyte in the body after subcutaneous injection) | 6 weeks |
| CL (total/apparent clearance of the analyte in plasma after intravascular administration) | 6 weeks |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | 6 weeks |
| V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose) | 6 weeks |
| V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration) | 6 weeks |
| V ss (apparent volume of distribution at steady state following intravascular administration) | 6 weeks |
| t max (time from dosing to maximum measured concentration) | 6 weeks |
| AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 6 weeks |
| AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured | 6 weeks |
| %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint | 6 weeks |
| delta z (terminal rate constant in plasma) | 6 weeks |
| t 1/2 (terminal half-life of the analyte in plasma) | 6 weeks |
| MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) | 6 weeks |
| C max (maximum measured concentration of the analyte in plasma) | 6 weeks |
Countries
Germany
Outcome results
None listed