Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial

A Randomized, Open-label, Parallel-group, Single Subcutaneous Dose, Relative Bioavailability Study of the Pharmacokinetics of Lulizumab (BMS-931699) From Prefilled Syringe (Process A) Compared to Drug in Vial (Process A) in Healthy Participants

A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial

Inclusion Criteria:

• Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
• All participants must have hemoglobin, hematocrit, and platelets within normal limits at screening
• All participants must have activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits at screening

Exclusion Criteria:

• Any current or past history or risk for tuberculosis:
• Active tuberculosis requiring treatment within the previous 3 years. All participants will be required to have a QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed at screening. Also excluded are participants with evidence of a past tuberculosis infection without documented adequate therapy. Participants with a positive QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test at screening will not be eligible for the study. A QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed within 4 weeks of dosing on Day 1 is acceptable as long as there is documentation of a negative result.
• Current clinical, radiographic, or laboratory evidence of active tuberculosis
• A history of herpes zoster