Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C

NCT00952263 | Completed Phase 1

• 1 other identifier: CA-HCV1-09-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Hepatitis C; Phase I; Infusion; Pharmacokinetics; MBL-HCV1; Monoclonal antibody; Safety Assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine pharmacokinetics of a human monoclonal antibody against Hepatitis C E2 glycoprotein (MBL-HCV1) given as a single intravenous infusion.

  56 days

Study Arms (1)

MBL-HCV1

EXPERIMENTAL

Biological: MBL-HCV1

Interventions

MBL-HCV1 BIOLOGICAL

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.

MBL-HCV1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Study subject must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.
• Be \> or equal to 18 years of age and \< or equal to 55 years of age.

You may not qualify if:

• No use of any tobacco products for at least 6 months.
• 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.
• Sexually active male subjects must use a barrier method of contraception during the course of the study.
• 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)
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.

Sponsors & Collaborators

• MassBiologics: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Suzanne Swan, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

US (1)