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
64 participants
INTERVENTIONAL
2008-05-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
Interventions
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SPC3649
Eligibility Criteria
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Inclusion Criteria
* BMI: 19-28 kg/m2
* No clinically significant disease/disorder
* Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
* Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.
Exclusion Criteria
* Alcohol intake\> 21 units weekly
* Regular smoker
* Received experimental drug within 30 days of study entry
* Planned participation in any experimental study during the study period
* HIV-Ab, HBsAg and/or HCV Ab positive
* History of specific allergy
* Current use of any drug or narcotics.
18 Years
45 Years
MALE
Yes
Sponsors
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Santaris Pharma A/S
INDUSTRY
Responsible Party
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Santaris Pharma
Locations
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PhaseOne Trials, Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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EudraCT nummer 2008-001012-20
Identifier Type: -
Identifier Source: secondary_id
SPC3649-201
Identifier Type: -
Identifier Source: org_study_id
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