NCT01510782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

January 12, 2012

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Changes in vital signs (blood pressure [BP], pulse rate [PR])

    up to 70 days post treatment

  • Changes in 12-lead ECG (electrocardiogram)

    up to 70 days post treatment

  • Incidence of adverse events

    up to 70 days post treatment

  • Assessment of global tolerability by investigator

    up to 70 days post treatment

  • Assessment of local tolerability by investigator

    up to 70 days post treatment

Secondary Outcomes (3)

  • Maximum measured concentration of the analyte in plasma

    up to 1656 hours post treatment

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

    up to 1656 hours post treatment

  • 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

    up to 1656 hours post treatment

Study Arms (4)

BI 655064 subcutaneous

EXPERIMENTAL

Escalating single dose as solution for subcutaneous injection

Drug: BI 655064

Placebo to BI 655064 subcutaneous

PLACEBO COMPARATOR

Escalation single dose as solution for subcutaneous injection (Placebo)

Drug: Placebo to BI 655064

BI 655064 intravenous

EXPERIMENTAL

Escalating single dose as solution for intravenous infusion

Drug: BI 655064

Placebo to BI 655064 intravenous

PLACEBO COMPARATOR

Escalating single dose as solution for intravenous infusion (Placebo)

Drug: Placebo to BI 655064

Interventions

Placebo to BI 655064DRUG

intravenous infusion of escalating doses

Placebo to BI 655064 intravenous
BI 655064DRUG

intravenous infusion of escalating doses

BI 655064 intravenous

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1293.1.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Related Publications (1)

  • Albach FN, Wagner F, Huser 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.

    PMID: 29127458DERIVED

MeSH Terms

Interventions

BI 655064

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 16, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)