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).
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Hanmi Clinical
Estado de México, State of Mexico, Mexico
RECRUITINGHCV RNA Viral load
Time frame: 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
Time frame: Through study week 32
Rapid virologic response (RVR)
Time frame: Study Week 4
Early virologic response (EVR)
Time frame: Study week 12
Sustained virologic response (SVR)
Time frame: Study week 24
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