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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1005273 s.c.; Drug: BI 1005273 i.v.; Drug: BI 105273 i.v. Placebo; Drug: BI 1005273 s.c. Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01650155

2011-004987-30 (EudraCT Number)

1294.1

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects

Exclusion criteria

1. Any deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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88 participants in 4 patient groups, including a placebo group

BI 1005273 i.v.

Experimental group

Description:

single dose i.v. infusion

Treatment:

Drug: BI 1005273 i.v.

BI 1005273 i.v. Placebo

Placebo Comparator group

Description:

single dose i.v. infusion (Placebo)

Treatment:

Drug: BI 105273 i.v. Placebo

BI 1005273 s.c.

Experimental group

Description:

single dose s.c. injection

Treatment:

Drug: BI 1005273 s.c.

BI 1005273 s.c. Placebo

Placebo Comparator group

Description:

single dose s.c. injection (Placebo)

Treatment:

Drug: BI 1005273 s.c. Placebo