Clinical trial: 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)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Contradiction