Chronic Hepatitis C Virus Genotype I
Conditions
Brief summary
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
* 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.
Interventions
DRUGHM10660A
DRUGPegasys
180 mcg Pegasys SC once weekly
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA Viral load | Through study week 32 | — |
| Safety/tolerability | Through study week 32 | symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation |
Secondary
| Measure | Time frame |
|---|---|
| Rapid virologic response (RVR) | Study Week 4 |
| Early virologic response (EVR) | Study week 12 |
| Sustained virologic response (SVR) | Study week 24 |
Countries
Mexico
Contacts
Primary ContactHanmi Clinical
Outcome results
None listed