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Completed

NCT Number: NCT01378364

Phase I Study of AbGn-168H in Healthy Male Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1304.1.4901 Boehringer Ingelheim Investigational Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
  • 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
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Use of biologic agents within 12 weeks prior to treatment

Treatment and study plan

AbGn-168H

Drug

single very low dose of AbGn-168H i.v.

Placebo

Drug

single dose of Placebo i.v.

Primary outcomes

  1. 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

    Time frame: 6 weeks

Secondary outcomes

  1. MRT sc (mean residence time of the analyte in the body after subcutaneous injection)

    Time frame: 6 weeks

  2. CL (total/apparent clearance of the analyte in plasma after intravascular administration)

    Time frame: 6 weeks

  3. CL/F (apparent clearance of the analyte in plasma after extravascular administration)

    Time frame: 6 weeks

  4. V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)

    Time frame: 6 weeks

  5. V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)

    Time frame: 6 weeks

  6. V ss (apparent volume of distribution at steady state following intravascular administration)

    Time frame: 6 weeks

  7. C max (maximum measured concentration of the analyte in plasma)

    Time frame: 6 weeks

  8. t max (time from dosing to maximum measured concentration)

    Time frame: 6 weeks

  9. AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: 6 weeks

  10. 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

    Time frame: 6 weeks

  11. %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint

    Time frame: 6 weeks

  12. delta z (terminal rate constant in plasma)

    Time frame: 6 weeks

  13. t 1/2 (terminal half-life of the analyte in plasma)

    Time frame: 6 weeks

  14. MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
First posted
Jun 22, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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