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

NCT ID: NCT01378364

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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AbGn-168H very low dose i.v.

subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo

Group Type EXPERIMENTAL

AbGn-168H

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

single dose of Placebo i.v.

AbGn-168H low dose i.v.

subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo

Group Type EXPERIMENTAL

AbGn-168H

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

single dose of Placebo i.v.

AbGn-168H medium dose i.v.

subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

single dose of Placebo i.v.

AbGn-168H

Intervention Type DRUG

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

AbGn-168H high dose i.v.

subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

single dose of Placebo i.v.

AbGn-168H

Intervention Type DRUG

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

AbGn-168H very low dose s.c.

subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo

Group Type EXPERIMENTAL

AbGn-168H

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

single dose of Placebo s.c.

AbGn-168H medium dose s.c.

subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

single dose of Placebo s.c.

AbGn-168H

Intervention Type DRUG

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

Interventions

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AbGn-168H

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

Intervention Type DRUG

AbGn-168H

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

Intervention Type DRUG

Placebo

single dose of Placebo i.v.

Intervention Type DRUG

Placebo

single dose of Placebo i.v.

Intervention Type DRUG

Placebo

single dose of Placebo i.v.

Intervention Type DRUG

Placebo

single dose of Placebo i.v.

Intervention Type DRUG

AbGn-168H

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

Intervention Type DRUG

AbGn-168H

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

Intervention Type DRUG

AbGn-168H

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

Intervention Type DRUG

Placebo

single dose of Placebo s.c.

Intervention Type DRUG

Placebo

single dose of Placebo s.c.

Intervention Type DRUG

AbGn-168H

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males according to following criteria:

Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
3. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
4. Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months
5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
6. Use of biologic agents within 12 weeks prior to treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1304.1.4901 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-000713-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1304.1

Identifier Type: -

Identifier Source: org_study_id