Phase I Study of AbGn-168H in Healthy Male Volunteers

Summary

The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.

Conditions

• Healthy

Interventions

DRUG

AbGn-168H

single very low dose of AbGn-168H i.v.

DRUG

AbGn-168H

single low dose of AbGn-168H i.v.

DRUG

Placebo

single dose of Placebo i.v.

DRUG

Placebo

single dose of Placebo i.v.

DRUG

Placebo

single dose of Placebo i.v.

DRUG

Placebo

single dose of Placebo i.v.

DRUG

AbGn-168H

single medium dose of AbGn-168H i.v.

DRUG

AbGn-168H

single high dose of AbGn-168H i.v.

DRUG

AbGn-168H

single low dose of AbGn-168H s.c.

DRUG

Placebo

single dose of Placebo s.c.

DRUG

Placebo

single dose of Placebo s.c.

DRUG

AbGn-168H

single medium dose of AbGn-168H s.c.

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2011-11-30

Countries

• Germany

Study Locations