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Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

NCT02145234

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Adults

Interventions: BMS-986089, Placebo matching with BMS-986089

Countries: United States

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
* Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
* Women must not be breastfeeding
* Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year

Exclusion Criteria:

* Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
* Any condition that will clearly require medical or surgical treatment during the period of study participation
* Any bone trauma or bone surgery within 3 months of study drug administration
* Known or suspected autoimmune disorder
* Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study

Locations (1)

Cypress, California, United States