drugset / Trial / NCT00952263
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion. A single dose of human monoclonal antibody will be administered. The study duration is 56 days. During this time, safety will be assessed via physical examinations, laboratory testing, concomitant medication usage and review of treatment emergent adverse events should they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during the 56 day study.
Timeline
- Start
- 2009-07
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MBL-HCV1 | Monoclonal antibody | 1 mg/kg | Other |
| Subject | MBL-HCV1 | Monoclonal antibody | 3 mg/kg | Other |
| Subject | MBL-HCV1 | Monoclonal antibody | 10 mg/kg | Other |
| Subject | MBL-HCV1 | Monoclonal antibody | 30 mg/kg | Other |
| Subject | MBL-HCV1 | Monoclonal antibody | 50 mg/kg | Other |
Indications
No indication recorded.