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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03058822

Enrollment

Registered

2017-02-23

Start date

2017-01-25

Completion date

2017-03-30

Last updated

2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGBMS-931699

BMS-931699 single subcutaneous dose on Day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026