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

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Chronic Hepatitis C Virus Genotype I

Treatments: Drug: HM10660A; Drug: Pegasys

Study type: Interventional

Funder types: Industry

Identifiers

NCT02057887

HM-IFN-201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Cohort1

Experimental group

Description:

HM10660A SC once weekly

Treatment:

Drug: HM10660A

Cohort2

Experimental group

Description:

HM10660A SC once every 2 weeks

Treatment:

Drug: HM10660A

Cohort3

Experimental group

Description:

HM10660A SC once every 4 weeks

Treatment:

Drug: HM10660A

Cohort4

Active Comparator group

Description:

180 mcg Pegasys SC once weekly

Treatment:

Drug: Pegasys