A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

Inclusion Criteria

• •A subject must meet all of the following criteria:
• •1. Willing and able to complete the informed consent process.
• •2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• •3. Available for clinical follow-up through the last study visit.
• •4. 18 to 60 years of age.
• •5. In good general health without clinically significant medical history.
• •6. Physical examination without clinically significant findings within the 56 days prior to enrollment.
• •7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group.
• •8. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
• •Laboratory Criteria within 56 days prior to enrollment:
• •9. White blood cell count (WBC): 2,500-12,000/mm3.
• •10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
• •11. Platelets: 125,000 - 500,000/mm3.
• •12. Hemoglobin within institutional normal range or accompanied by PI or designee approval.
• •13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN).
• •14. ALT: \<= 1.25 x ULN.
• •15. AST: \<= 1.25 x ULN.
• •16. Negative for HIV infection by an FDA approved method of detection.
• •Female-Specific Criteria:
• •17. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
• •18. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.