Status:
COMPLETED
Safety Study of SPC3649 in Healthy Men
Lead Sponsor:
Santaris Pharma A/S
Conditions:
Hepatitis C
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
Eligibility Criteria
Inclusion
- Healthy Volunteers
- 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
- Heavy exercise within the past 7 days
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
End Date :
May 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00688012
Start Date
May 1 2008
End Date
May 1 2009
Last Update
September 18 2009
Active Locations (1)
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1
PhaseOne Trials, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650