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

Chronic Hepatitis C Virus Genotype I Clinical Trial

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Genotype I
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT02057887
• Study type: Interventional
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Hanmi Clinical
• Email: clinical4@hanmi.co.kr
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2013