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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 655064; Drug: Placebo to BI 655064

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510782

2011-002251-34 (EudraCT Number)

1293.1

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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72 participants in 4 patient groups, including a placebo group

BI 655064 subcutaneous

Experimental group

Description:

Escalating single dose as solution for subcutaneous injection

Treatment:

Drug: BI 655064

Drug: BI 655064

Placebo to BI 655064 subcutaneous

Placebo Comparator group

Description:

Escalation single dose as solution for subcutaneous injection (Placebo)

Treatment:

Drug: Placebo to BI 655064

Drug: Placebo to BI 655064

BI 655064 intravenous

Experimental group

Description:

Escalating single dose as solution for intravenous infusion

Treatment:

Drug: BI 655064

Drug: BI 655064

Placebo to BI 655064 intravenous

Placebo Comparator group

Description:

Escalating single dose as solution for intravenous infusion (Placebo)

Treatment:

Drug: Placebo to BI 655064

Drug: Placebo to BI 655064