Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT00952263
- Run by
- MassBiologics
- People needed
- 31
- Starts
- 2009-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2016-09-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
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.
- 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)
You may not qualify if…
- 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.
Where it is running
- DaVita Clinical Research — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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