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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT02145234

Run by

Hoffmann-La Roche

People needed

140

Starts

2014-06-30

Expected to finish

2016-02-29

Last updated by the study team

2017-09-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wcct Global, Llc — Cypress, California, United States

Full record on ClinicalTrials.gov

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