Clinical trial NCT01378364: Phase I Study of AbGn-168H in Healthy Male Volunteers
Official title: Safety, Tolerability and Pharmacokinetics Study of Single Rising Doses of AbGn-168H Administered by Intravenous Infusion (125 μg/kg, 500 μg/kg, 1 mg/kg, 2 mg/kg) or Subcutaneous Injection (125 μg/kg, 1 mg/kg) to Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-06-22
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 weeks
Secondary outcomes:
measure: MRT sc (mean residence time of the analyte in the body after subcutaneous injection)
timeFrame: 6 weeks
measure: CL (total/apparent clearance of the analyte in plasma after intravascular administration)
timeFrame: 6 weeks
measure: CL/F (apparent clearance of the analyte in plasma after extravascular administration)
timeFrame: 6 weeks
measure: V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)
timeFrame: 6 weeks
measure: V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)
timeFrame: 6 weeks
measure: V ss (apparent volume of distribution at steady state following intravascular administration)
timeFrame: 6 weeks
measure: C max (maximum measured concentration of the analyte in plasma)
timeFrame: 6 weeks
measure: t max (time from dosing to maximum measured concentration)
timeFrame: 6 weeks
measure: AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: 6 weeks
measure: 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
timeFrame: 6 weeks
measure: %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint
timeFrame: 6 weeks
measure: delta z (terminal rate constant in plasma)
timeFrame: 6 weeks
measure: t 1/2 (terminal half-life of the analyte in plasma)
timeFrame: 6 weeks
measure: MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1304.1.4901 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: