Trials / Unknown
UnknownNCT02057887
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HM10660A | |
| DRUG | Pegasys | 180 mcg Pegasys SC once weekly |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-08-01
- First posted
- 2014-02-07
- Last updated
- 2014-02-07
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT02057887. Inclusion in this directory is not an endorsement.