Status:
COMPLETED
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
Lead Sponsor:
MassBiologics
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
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 h...
Eligibility Criteria
Inclusion
- 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.
- Be in general good health without history of any of the conditions listed in exclusion criteria.
- 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)
Exclusion
- Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
- Weight \>90 kg
- History of any of the following illnesses or conditions:
- Cancer
- Heart Disease
- Diabetes mellitus
- Respiratory condition (such as asthma requiring daily medication)
- Autoimmune disorder
- Blood dyscrasias
- Psychiatric disorder that precludes compliance with protocol
- Hepatitis
- Any chronic condition requiring daily prescription or over-the-counter medicine except for vitamins and birth control products.
- Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of monoclonal antibody administration.
- History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
- Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
- Systolic blood pressure \>140 or \< 90 and/or diastolic blood pressure \>90 on two separate readings.
- Urinalysis positive for \> trace protein, \>5 rbc/hpf or \>5 wbc/hpf
- Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
- Positive urine pregnancy test during screening or within 24 hours of monoclonal antibody administration, or an unwillingness to undergo pregnancy testing.
- Breast-feeding.
- Receipt of licensed vaccine or other investigational study agent within previous 30 days.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00952263
Start Date
July 1 2009
End Date
December 1 2009
Last Update
September 15 2016
Active Locations (1)
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1
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404