{
  "FullStudy":{
    "Rank":218249,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510782",
          "OrgStudyIdInfo":{
            "OrgStudyId":"1293.1"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-002251-34",
                "SecondaryIdType":"EudraCT Number",
                "SecondaryIdDomain":"EudraCT"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Boehringer Ingelheim",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers",
          "OfficialTitle":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 31, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 1, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Boehringer Ingelheim",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"72",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"BI 655064 subcutaneous",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Escalating single dose as solution for subcutaneous injection",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: BI 655064"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo to BI 655064 subcutaneous",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Escalation single dose as solution for subcutaneous injection (Placebo)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo to BI 655064"
                  ]
                }
              },{
                "ArmGroupLabel":"BI 655064 intravenous",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Escalating single dose as solution for intravenous infusion",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: BI 655064"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo to BI 655064 intravenous",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Escalating single dose as solution for intravenous infusion (Placebo)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo to BI 655064"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Placebo to BI 655064",
                "InterventionDescription":"intravenous infusion of escalating doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo to BI 655064 intravenous"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo to BI 655064",
                "InterventionDescription":"subcutaneous injection of escalating doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo to BI 655064 subcutaneous"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"BI 655064",
                "InterventionDescription":"intravenous infusion of escalating doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "BI 655064 intravenous"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"BI 655064",
                "InterventionDescription":"subcutaneous injection of escalating doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "BI 655064 subcutaneous"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Changes in vital signs (blood pressure [BP], pulse rate [PR])",
                "PrimaryOutcomeTimeFrame":"up to 70 days post treatment"
              },{
                "PrimaryOutcomeMeasure":"Changes in 12-lead ECG (electrocardiogram)",
                "PrimaryOutcomeTimeFrame":"up to 70 days post treatment"
              },{
                "PrimaryOutcomeMeasure":"Incidence of adverse events",
                "PrimaryOutcomeTimeFrame":"up to 70 days post treatment"
              },{
                "PrimaryOutcomeMeasure":"Assessment of global tolerability by investigator",
                "PrimaryOutcomeTimeFrame":"up to 70 days post treatment"
              },{
                "PrimaryOutcomeMeasure":"Assessment of local tolerability by investigator",
                "PrimaryOutcomeTimeFrame":"up to 70 days post treatment"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Maximum measured concentration of the analyte in plasma",
                "SecondaryOutcomeTimeFrame":"up to 1656 hours post treatment"
              },{
                "SecondaryOutcomeMeasure":"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity",
                "SecondaryOutcomeTimeFrame":"up to 1656 hours post treatment"
              },{
                "SecondaryOutcomeMeasure":"Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose",
                "SecondaryOutcomeTimeFrame":"up to 1656 hours post treatment"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria:\n\n1. Healthy male subjects\n\nExclusion criteria:\n\n1. Any relevant deviation from healthy conditions",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Boehringer Ingelheim",
                "OverallOfficialAffiliation":"Boehringer Ingelheim",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"1293.1.1 Boehringer Ingelheim Investigational Site",
                "LocationCity":"Berlin",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29127458",
                "ReferenceType":"derived",
                "ReferenceCitation":"Albach FN, Wagner F, Hüser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}