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Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

NCT ID: NCT01510782

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 655064 subcutaneous

Escalating single dose as solution for subcutaneous injection

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

subcutaneous injection of escalating doses

Placebo to BI 655064 subcutaneous

Escalation single dose as solution for subcutaneous injection (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo to BI 655064

Intervention Type DRUG

subcutaneous injection of escalating doses

BI 655064 intravenous

Escalating single dose as solution for intravenous infusion

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

intravenous infusion of escalating doses

Placebo to BI 655064 intravenous

Escalating single dose as solution for intravenous infusion (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo to BI 655064

Intervention Type DRUG

intravenous infusion of escalating doses

Interventions

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Placebo to BI 655064

intravenous infusion of escalating doses

Intervention Type DRUG

Placebo to BI 655064

subcutaneous injection of escalating doses

Intervention Type DRUG

BI 655064

intravenous infusion of escalating doses

Intervention Type DRUG

BI 655064

subcutaneous injection of escalating doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1293.1.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29127458 (View on PubMed)

Other Identifiers

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2011-002251-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293.1

Identifier Type: -

Identifier Source: org_study_id