Hepatitis C liver inflammation
Conditions
Interventions
Treatment with SPC3649
Sponsors
Santaris Pharma A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of multiple dosing of SPC3649 | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers • To evaluate the bioavailability of s.c. administration of SPC3649 • To investigate the effect of multiple dosing of SPC3649 on lipids as surrogate markers of miR-122 inhibition | — |
Countries
Netherlands
Outcome results
None listed