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

Inclusion criteria

• Capable of giving written informed consent and able to effectively communicate with the Investigator and study personnel. A signed informed consent form (ICF) must be on file prior to initiating the screening procedures.
• Willing and able to complete all study requirements, restrictions, visits and procedures.
• Negative for serum anti-B. burgdorferi antibodies by an FDA approved modified two-tier ELISA test.
• Age 19 to 65 years, inclusive.
• Weight 50 kg to 105 kg, inclusive.
• Seated blood pressure is greater than 90/40 mmHg or less than 140/90 mmHg at the screening visit, and seated heart rate is higher than 40 bpm or lower than 99 bpm at the screening visit.
• Women of reproductive potential must agree not to become pregnant for at least 12 months after the study product administration. 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.
• Males of reproductive potential must use a barrier method of contraception during the course of the study.
• Screening laboratory values must meet the following criteria:

• WBC > 3,900 and < 11,000/mm3
• Platelets > 100,000/mm3
• Hemoglobin > 10.5 gm/dl
• Creatinine ≤ ULN
• BUN ≤ ULN
• AST ≤ ULN
• ALT ≤ ULN
• Alkaline Phosphatase ≤ ULN
• Total Bilirubin < 1.5 x ULN AND Direct Bilirubin ≤ ULN
• HgbA1c ≤ 6.4

Exclusion criteria

• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
• Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
• Regular use of more than 20 cigarettes per day (or equivalent amount of nicotine containing product)
• Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of study product administration.
• History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
• Any current medical or other condition that in the opinion of the PI would jeopardize the safety of the volunteer participating in the study.
• 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.
• Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
• Positive serum pregnancy test during screening or within 24 hours of study product administration, or an unwillingness to undergo pregnancy testing.
• Breast-feeding.
• Treatment with another investigational drug or other investigational intervention within 30 days of study drug dosing.
• Safety laboratory abnormalities at Screening or Day -1, which are clinically significant as determined by the PI.
• Tick bite within 4 weeks prior to screening.
• 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.

Potential study subjects who met all inclusion and none of the exclusion criteria, but who, for personal or administrative reasons, were not included in a study cohort, may be rescreened if more than 30 days have passed since their previous screening. There are no restrictions on the number of re-screens permitted for these subjects.