Safety Study of SPC3649 in Healthy Men
Phase 1
Completed
- Conditions
- Hepatitis C
- Registration Number
- NCT00688012
- Lead Sponsor
- Santaris Pharma A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PhaseOne Trials, Hvidovre University Hospital
🇩🇰Hvidovre, Denmark