Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C (MBL-HCV1)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Dose Escalation Phase I Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (MBL-HCV1) Against Hepatitis C E2 Glycoprotein|
- Assess safety and tolerability of escalating doses of a human monoclonal antibody against Hepatitis C E2 glycoprotein (MBL-HCV1) in healthy adults. [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
- Determine pharmacokinetics of a human monoclonal antibody against Hepatitis C E2 glycoprotein (MBL-HCV1) given as a single intravenous infusion. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Single infusion of MBL-HCV1 at escalating doses as determined by cohort assignment: Cohort 1 @ 1 mg/kg, Cohort 2 @ 3 mg/kg, Cohort 3 @ 10 mg/kg, Cohort 4 @ 30 mg/kg, Cohort 5 @ 50 mg/kg.
This is a phase I, open-label, dose escalation study in healthy adult volunteers. Eligible volunteers will be admitted to a phase I unit for study infusion and be discharged after collection of a 24 hour post infusion sample. Thirty subjects are anticipated to be enrolled. There will be five cohorts of 6 subjects each. A single dose of human monoclonal antibody MBL-HCV1 will be administered on Day 0 and subjects will be followed for 56 days. Dose escalation to the next cohort will occur after review of safety data by the principal investigator, sponsor and an independent safety monitor through day 10 for all subjects in a cohort. Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, electrocardiograms, use of concomitant medications and review of treatment-emergent adverse events should they occur. Subjects will be evaluated at study visits on days 0, 1, 2, 3, 7, 14+/-1, 28+/-3 and 56+/-7. Blood samples and urinalysis for safety analyses will be drawn during screening and on days 0, 1, 3, 7 and 28+/-3. Blood samples for Pharmacokinetic analysis will be drawn on days 0, 1, 2, 3, 7, 14+/-1, 28+/-3 and 56+/-7. Blood samples for human anti-human antibody detection will be drawn on days 0, 14+/-1 and 56+/-7.
|United States, Minnesota|
|DaVita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Suzanne Swan, MD||Davita Clinical Research|