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

Phase 1

• Conditions: Chronic Hepatitis C Virus Genotype I
• Interventions: Drug: HM10660A; Drug: Pegasys

• Registration Number: NCT02057887
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-08
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07
• Primary Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort1	HM10660A	HM10660A SC once weekly
Cohort2	HM10660A	HM10660A SC once every 2 weeks
Cohort3	HM10660A	HM10660A SC once every 4 weeks
Cohort4	Pegasys	180 mcg Pegasys SC once weekly

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rapid virologic response (RVR)	Study Week 4
Early virologic response (EVR)	Study week 12
Sustained virologic response (SVR)	Study week 24

Trial Locations

Locations (1)

Hanmi Clinical; 🇲🇽 Estado de Mexico, Mexico