First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People

Exclusion Criteria

• •1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
• •2. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
• •3. Regular use of more than 20 cigarettes per day (or equivalent amount of nicotine containing product)
• •4. Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of study product administration.
• •5. History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
• •6. Any current medical or other condition that in the opinion of the PI would jeopardize the safety of the volunteer participating in the study.
• •7. Clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease, as determined by the PI. The investigator will consider all conditions, which could conceivably increase risk to the subjects, alter study drug metabolism, or jeopardize data integrity as clinically significant when making this determination.
• •8. Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
• •9. Positive serum pregnancy test during screening or within 24 hours of study product administration, or an unwillingness to undergo pregnancy testing.
• •10. Breast-feeding.
• •11. Treatment with another investigational drug or other investigational intervention within 30 days of study drug dosing.
• •12. Safety laboratory abnormalities at Screening or Day -1, which are clinically significant as determined by the PI.
• •13. Tick bite within 4 weeks prior to screening.
• •14. Receipt of any Lyme disease vaccine.
• •Abnormal ECG or laboratory parameters may be repeated once, if in the opinion of the PI, the results are due to technical factors or are inconsistent with the potential subject's medical evaluation.