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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

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).

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort1

HM10660A SC once weekly

Group Type EXPERIMENTAL

HM10660A

Intervention Type DRUG

Cohort2

HM10660A SC once every 2 weeks

Group Type EXPERIMENTAL

HM10660A

Intervention Type DRUG

Cohort3

HM10660A SC once every 4 weeks

Group Type EXPERIMENTAL

HM10660A

Intervention Type DRUG

Cohort4

180 mcg Pegasys SC once weekly

Group Type ACTIVE_COMPARATOR

Pegasys

Intervention Type DRUG

180 mcg Pegasys SC once weekly

Interventions

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HM10660A

Intervention Type DRUG

Pegasys

180 mcg Pegasys SC once weekly

Intervention Type DRUG

Other Intervention Names

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Laps-IFNa

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No