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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01378364
First received: June 21, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AbGn-168H
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRT sc (mean residence time of the analyte in the body after subcutaneous injection) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • CL (total/apparent clearance of the analyte in plasma after intravascular administration) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • V ss (apparent volume of distribution at steady state following intravascular administration) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • C max (maximum measured concentration of the analyte in plasma) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • t max (time from dosing to maximum measured concentration) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • delta z (terminal rate constant in plasma) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • t 1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AbGn-168H very low dose i.v.
subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo
Drug: AbGn-168H
single very low dose of AbGn-168H i.v.
Drug: Placebo
single dose of Placebo i.v.
Experimental: AbGn-168H low dose i.v.
subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo
Drug: AbGn-168H
single low dose of AbGn-168H i.v.
Drug: Placebo
single dose of Placebo i.v.
Experimental: AbGn-168H medium dose i.v.
subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo
Drug: Placebo
single dose of Placebo i.v.
Drug: AbGn-168H
single medium dose of AbGn-168H i.v.
Experimental: AbGn-168H high dose i.v.
subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo
Drug: Placebo
single dose of Placebo i.v.
Drug: AbGn-168H
single high dose of AbGn-168H i.v.
Experimental: AbGn-168H very low dose s.c.
subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo
Drug: AbGn-168H
single low dose of AbGn-168H s.c.
Drug: Placebo
single dose of Placebo s.c.
Experimental: AbGn-168H medium dose s.c.
subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo
Drug: Placebo
single dose of Placebo s.c.
Drug: AbGn-168H
single medium dose of AbGn-168H s.c.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378364

Locations
Germany
1304.1.4901 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01378364     History of Changes
Other Study ID Numbers: 1304.1, 2011-000713-39
Study First Received: June 21, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Paul-Ehrlich-Institute

ClinicalTrials.gov processed this record on July 22, 2014