Study Results
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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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
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
AbGn-168H
single very low dose of AbGn-168H i.v.
Placebo
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
AbGn-168H
single low dose of AbGn-168H i.v.
Placebo
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
Placebo
single dose of Placebo i.v.
AbGn-168H
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
Placebo
single dose of Placebo i.v.
AbGn-168H
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
AbGn-168H
single low dose of AbGn-168H s.c.
Placebo
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
Placebo
single dose of Placebo s.c.
AbGn-168H
single medium dose of AbGn-168H s.c.
Interventions
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AbGn-168H
single very low dose of AbGn-168H i.v.
AbGn-168H
single low dose of AbGn-168H i.v.
Placebo
single dose of Placebo i.v.
Placebo
single dose of Placebo i.v.
Placebo
single dose of Placebo i.v.
Placebo
single dose of Placebo i.v.
AbGn-168H
single medium dose of AbGn-168H i.v.
AbGn-168H
single high dose of AbGn-168H i.v.
AbGn-168H
single low dose of AbGn-168H s.c.
Placebo
single dose of Placebo s.c.
Placebo
single dose of Placebo s.c.
AbGn-168H
single medium dose of AbGn-168H s.c.
Eligibility Criteria
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Inclusion 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
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
18 Years
50 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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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
Countries
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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
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