Healthy
Conditions
Keywords
Hepatitis C, Phase I, Infusion, Pharmacokinetics, MBL-HCV1, Monoclonal antibody, Safety Assessment
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALMBL-HCV1
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.
Sponsors
MassBiologics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Study subject must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained. 2. Be \> or equal to 18 years of age and \< or equal to 55 years of age. 3. Be in general good health without history of any of the conditions listed in
Exclusion criteria
. 4. No use of any tobacco products for at least 6 months. 5. A woman must agree not to become pregnant from the time of study enrollment until at least 3 months after the completion of the monoclonal antibody infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel. 6. Sexually active male subjects must use a barrier method of contraception during the course of the study. 7. Screening laboratory values must meet the following criteria: * WBC (\>3,900 - \<11,000/mm\^3) * Platelets(\>100,000/mm\^3) * Hemoglobin (\>10.5 gm/dl) * Creatinine (\<1.1 x ULN) * BUN (\<1.25 x ULN) * AST(\<1.1 x ULN) * ALT (\<1.1 x ULN) * Alkaline Phosphatase (\<1.1 x ULN) * Bilirubin (\<1.1 x ULN) * Glucose-nonfasting (\>/=60 mg/dl and \</=115 mg/dl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety and tolerability of escalating doses of a human monoclonal antibody against Hepatitis C E2 glycoprotein (MBL-HCV1) in healthy adults. | 56 days |
Secondary
| Measure | Time frame |
|---|---|
| Determine pharmacokinetics of a human monoclonal antibody against Hepatitis C E2 glycoprotein (MBL-HCV1) given as a single intravenous infusion. | 56 days |
Countries
United States
Outcome results
None listed