A placebo-controlled, double-blind, randomised, multiple dose, dose escalating study in healthy subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649
- Conditions
- Hepatitis Cliver inflammation10047438
- Registration Number
- NL-OMON33484
- Lead Sponsor
- Santaris Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
• Healthy volunteers
• Males, postmenopausal (>1 year since last menstruation) or hysterectomised female
• Age >=18 to 60 years
• BMI: 18 - 30 kg/m2
• No clinically significant disease/disorder
• No clinically significant abnormalities at Screening laboratory tests
• Male subjects must agree to use birth control (condoms) during the whole study period
• 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
• Alcohol intake >=21 units weekly for men, and >=14 units for women
• smoke >10 cigarettes per day
• Received experimental drug within 60 days of study entry
• Planned participation in any experimental study during the study period
• HIV-Ab, HBsAg and/or HCV Ab positive
• Abnormal blood pressure (systolic >140 mmHg and/or diastolic blood pressure >90 mmHg)
• Current use of any drug or narcotics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety and tolerability of multiple dosing of SPC3649</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649<br /><br>administered by i.v. and s.c. route in healthy volunteers<br /><br>• To evaluate the bioavailability of s.c. administration of SPC3649<br /><br>• To investigate the effect of multiple dosing of SPC3649 on lipids as<br /><br>surrogate markers of miR-122 inhibition</p><br>