Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

Detailed Description
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To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection. To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection. To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.

Conditions
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Chronic Hepatitis C Virus Genotype I

Intervention / Treatment
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* Drug: HM10660A
* Drug: Pegasys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 to 65 years old, inclusive Willing and able to provide written informed consent. Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening. HCV genotype 1a or 1b. Body mass index (BMI) between 18 and 38 kg/m2. Willing and able to comply with the protocol and available to complete the study schedule of assessments. Exclusion Criteria: Pregnant women or women who may wish to become pregnant during the course of the study. Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV. Evidence of infection or co-infection with a non-genotype 1 HCV strain. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV). Lactating females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort1<br>HM10660A SC once weekly | Drug: HM10660A<br> <br> * Other names: Laps-IFNa;|
| Experimental: Cohort2<br>HM10660A SC once every 2 weeks | Drug: HM10660A<br> <br> * Other names: Laps-IFNa;|
| Experimental: Cohort3<br>HM10660A SC once every 4 weeks | Drug: HM10660A<br> <br> * Other names: Laps-IFNa;|
| Active Comparator: Cohort4<br>180 mcg Pegasys SC once weekly | Drug: Pegasys<br>* 180 mcg Pegasys SC once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA Viral load |  | Through study week 32 | 
| Safety/tolerability | symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation | Through study week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid virologic response (RVR) |  | Study Week 4 | 
| Early virologic response (EVR) |  | Study week 12 | 
| Sustained virologic response (SVR) |  | Study week 24 |