Phase I Study of AbGn-168H in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: AbGn-168H
- Registration Number
- NCT01378364
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AbGn-168H medium dose s.c. Placebo subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo AbGn-168H medium dose s.c. AbGn-168H subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo AbGn-168H very low dose i.v. AbGn-168H subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H low dose i.v. AbGn-168H subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H very low dose i.v. Placebo subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H high dose i.v. AbGn-168H subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H low dose i.v. Placebo subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H medium dose i.v. Placebo subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H medium dose i.v. AbGn-168H subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H high dose i.v. Placebo subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo AbGn-168H very low dose s.c. AbGn-168H subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo AbGn-168H very low dose s.c. Placebo subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) 6 weeks 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 C max (maximum measured concentration of the analyte in plasma) 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
Trial Locations
- Locations (1)
1304.1.4901 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany