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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510782

Enrollment

Registered

2012-01-16

Start date

2012-01-31

Completion date

2012-09-30

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGPlacebo to BI 655064

intravenous infusion of escalating doses

DRUGBI 655064

intravenous infusion of escalating doses

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Healthy male subjects

Exclusion criteria

1\. Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
Assessment of local tolerability by investigator	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
Changes in vital signs (blood pressure [BP], pulse rate [PR])	up to 70 days post treatment

Secondary

Measure	Time frame
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
Maximum measured concentration of the analyte in plasma	up to 1656 hours post treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026