Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 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

NCT01650155

Enrollment

Registered

2012-07-26

Start date

2012-07-31

Completion date

2014-09-30

Last updated

2014-10-16

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 the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

Interventions

DRUGBI 1005273 s.c.

injection

DRUGBI 105273 i.v. Placebo

infusion

DRUGBI 1005273 s.c. Placebo

injection

DRUGBI 1005273 i.v.

infusion

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Healthy male subjects

Exclusion criteria

1\. Any deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
number (% subjects) with drug-related AEs.	day -21 to day 95

Secondary

Measure	Time frame
Cmax (maximum measured concentration of the analyte in plasma)	day 1 to day 90
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	day 1 to day 90
AUC0-tz (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)	day 1 to day 90

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026