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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: BMS-931699

Study type

Interventional

Funder types

Industry

Identifiers

NCT03058822
IM128-037

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 6 patient groups

Prefilled Syringe Upper Arm
Experimental group
Description:
Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699
Treatment:
Drug: BMS-931699
Prefilled Syringe Thigh
Experimental group
Description:
Single subcutaneous dose from prefilled syringe into thigh of BMS-931699
Treatment:
Drug: BMS-931699
Prefilled Syringe Abdomen
Experimental group
Description:
Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699
Treatment:
Drug: BMS-931699
Drug in Vial Upper Arm
Experimental group
Description:
Single subcutaneous dose from drug in vial into upper arm of BMS-931699
Treatment:
Drug: BMS-931699
Drug in Vial Thigh
Experimental group
Description:
Single subcutaneous dose from drug in vial into thigh of BMS-931699
Treatment:
Drug: BMS-931699
Drug in Vial Abdomen
Experimental group
Description:
Single subcutaneous dose from drug in vial into abdomen of BMS-931699
Treatment:
Drug: BMS-931699

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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