Hepatitis C
Conditions
Keywords
antisense, microRna antagonist, anti-miR-122, Safety in healthy volunteers, Hepatitis C
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.
Interventions
DRUGSPC3649
Sponsors
Santaris Pharma A/S
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Countries
Denmark
Outcome results
None listed