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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-931699


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prefilled Syringe Upper Arm<br>Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|
| Experimental: Prefilled Syringe Thigh<br>Single subcutaneous dose from prefilled syringe into thigh of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|
| Experimental: Prefilled Syringe Abdomen<br>Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|
| Experimental: Drug in Vial Upper Arm<br>Single subcutaneous dose from drug in vial into upper arm of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|
| Experimental: Drug in Vial Thigh<br>Single subcutaneous dose from drug in vial into thigh of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|
| Experimental: Drug in Vial Abdomen<br>Single subcutaneous dose from drug in vial into abdomen of BMS-931699 | Drug: BMS-931699<br>* BMS-931699 single subcutaneous dose on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants |  | 43 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of BMS-931699 following a single prefilled syringe or drug in vial subcutaneous dose in healthy participants by assessing adverse events and other physical assessments throughout study conduct |  | 43 days |