Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.
NCT01650155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2014-10-16
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.
Conditions
- Healthy
Interventions
- DRUG
-
BI 1005273 s.c.
injection
- DRUG
-
BI 105273 i.v. Placebo
infusion
- DRUG
-
BI 1005273 s.c. Placebo
injection
- DRUG
-
BI 1005273 i.v.
infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2014-09-30
- Completion
- 2014-09-30
Countries
- Germany
Study Locations
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