We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01378364
First Posted: June 22, 2011
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Single Group Assignment
Masking: Double
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 ]

Secondary Outcome Measures:
  • MRT sc (mean residence time of the analyte in the body after subcutaneous injection) [ Time Frame: 6 weeks ]
  • CL (total/apparent clearance of the analyte in plasma after intravascular administration) [ Time Frame: 6 weeks ]
  • CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: 6 weeks ]
  • V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose) [ Time Frame: 6 weeks ]
  • V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration) [ Time Frame: 6 weeks ]
  • V ss (apparent volume of distribution at steady state following intravascular administration) [ Time Frame: 6 weeks ]
  • C max (maximum measured concentration of the analyte in plasma) [ Time Frame: 6 weeks ]
  • t max (time from dosing to maximum measured concentration) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 6 weeks ]
  • %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint [ Time Frame: 6 weeks ]
  • delta z (terminal rate constant in plasma) [ Time Frame: 6 weeks ]
  • t 1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 6 weeks ]
  • MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01378364     History of Changes
Other Study ID Numbers: 1304.1
2011-000713-39 ( EudraCT Number: EudraCT )
First Submitted: June 21, 2011
First Posted: June 22, 2011
Last Update Posted: November 1, 2013
Last Verified: October 2013