A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infection

INTERVENTION: Product Name: Miravirsen Product Code: SPC3649 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: miravirsen Current Sponsor code: SPC3649 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Patients infected with chronic hepatitis C PRIMARY OUTCOME: Main Objective: The primary objective of this study is to determine the safety and tolerability of multiple doses of miravirsen in HCV genotype 1 infected subjects Primary end point(s): safety and tolerability Secondary Objective: The secondary objectives of this study are to:; a. assess the pharmacokinetics of miravirsen administered subcutaneously to HCV infected subjects; b. assess any effect on viral titer in subjects with HCV; INCLUSION CRITERIA: 1. Male or female, age 18 to 65 years, inclusive 2. BMI 18‐38 kg/m2 3. Treatment‐naïve to interferon‐alpha based therapies 4. HCV genotype 1 5. Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C (CHC), including: a. Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment, OR b. Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C 6. Serum HCV RNA > 75,000 IU/mL at Screening 7. (North American sites only). Liver biopsy within 36 months of Day 1, indicating the absence of cirrhosis 8. Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met: a. Platelets >100,000/mm3 b. Total WBC > 3000/mm3 and AN