A Study of LY3016859 in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: LY3016859 intravenous; Placebo intravenous; LY3016859 subcutaneous; Placebo subcutaneous
Intervention description: Administered intravenously; Administered intravenously; Administered subcutaneously; Administered subcutaneously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the safety and tolerability of LY3016859
      administered as single doses, and to determine how long LY3016859 remains in the body
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women of non-childbearing potential as determined by medical history
             and physical examination (PE), and:

               -  Men agree to use 2 medically accepted methods of contraception with all sexual
                  partners during the study and for 90 days after the final dose

               -  Women are not of child-bearing potential due to surgical sterilization (at least
                  6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at
                  least 6 weeks after tubal ligation) confirmed by medical history, or
                  post-menopause. Post-menopausal status will be defined as a woman 45 years of age
                  or older with either 12 months of spontaneous amenorrhea, or 6-12 months of
                  spontaneous amenorrhea combined with follicle stimulating hormone (FSH) greater
                  than (>) 40 international units per liter (IU/L)

          -  Are reliable and are willing to make themselves available for the duration of the
             study, and are willing to follow site specific study procedures

          -  Must weigh greater than or equal to (≥) 50 kilograms (kg) at time of screening and
             dosing

          -  Have clinical laboratory test results within normal reference range for the
             investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

          -  Have venous access sufficient to allow blood sampling as per the protocol

          -  Must be a non-smoker

        Exclusion Criteria:

          -  Are currently enrolled in, or have discontinued within the last 60 days from a
             clinical trial involving an investigational drug that has not received regulatory
             approval for any indication, or have received treatment with biologic agents (such as
             monoclonal antibodies) within 3 months or 5 half-lives of the administered drug
             (whichever is longer) prior to dosing

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY3016859, and have previously received the investigational product

          -  Have a history or presence of medical illness including but not limited to any
             cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or
             neurological disease, or any clinically significant laboratory abnormality, that in
             the judgment of the investigator indicates a medical problem that would preclude study
             participation

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study or have:

               -  Confirmed corrected QT interval using Fridericia's formula (QTcF) > 450
                  milliseconds (msec) for men and > 470 msec for women

               -  Bundle branch blocks or other conduction abnormalities other than mild
                  first-degree atrio-ventricular block

               -  Irregular rhythms other than sinus arrhythmia or occasional, rare
                  supraventricular ectopic beats

               -  History of unexplained syncope

               -  Family history of unexplained sudden death or sudden death due to long QT
                  syndrome

               -  T-wave configurations are not of sufficient quality for assessing QT interval, as
                  determined by the investigator

          -  Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV
             antibodies, hepatitis C and/or positive hepatitis C antibody, or Hepatitis B and/or
             positive Hepatitis B surface antigen

          -  Show use of any medication with potential to mask allergic response for example (e.g.)
             antihistamines, systemic glucocorticoids or antipyretic agents) within 3 days of
             dosing (Note: Acetaminophen or nonsteroidal analgesics for headache may be allowed as
             needed in the Investigator's judgment. The following medications are also specifically
             allowed in this study: vitamins at normal replacement doses, hormone replacement
             therapies e.g. estrogen, thyroid hormone), topical medications with limited systemic
             effects (e.g. eye drops, skin creams, vaginal antifungals, hemorrhoid preparations,
             etcetera (etc.), stable preventive therapies for hyperlipidemia and gastric acidity
             disorders)

          -  Have donated blood of more than 500 milliliters (mL) within the last month.

          -  Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling
             to stop alcohol within 48 hours of entry into study and for the duration of the study
             [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of
             distilled spirits]

          -  Have an abnormal blood pressure (sitting) defined as diastolic blood pressure (DBP) >
             95 or less than (<) 50 millimeters of mercury (mmHg) and/or systolic blood pressure
             (SBP) > 150 or < 90 mmHg confirmed by at least 1 repeat measurement

          -  Have evidence of regular use of known drugs of abuse or show positive findings for
             such use on urinary drug screening

          -  Will donate blood or participate in another clinical trial within 3 months or 5
             half-lives of study drug (whichever is longer) of receiving the last study drug
             administration