A Study of LY2495655 in Healthy Subjects
Condition: Healthy Volunteer
Intervention: LY2495655; Placebo
Intervention description: administered intravenously or subcutaneously; administered intravenously or subcutaneously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 24 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.
    

Eligibility criteria:

        Inclusion Criteria

          -  Single dose cohort

               -  Overtly healthy males or females, as determined by medical history and physical
                  examination

               -  Between the ages of 24 and 50 years

          -  Multiple dose cohorts

               -  Sedentary males and females with stable medical problems, if any, that, in the
                  investigator's opinion, will not place the subject at increased risk by
                  participating in the study and will not interfere with interpretation of the data

               -  Between the ages of 50 and 85 years

               -  Score <600 Metabolic Equivalent Tasks (METs) per week based on International
                  Physical Activity Questionnaire (IPAQ)

          -  All subjects

               -  Male subjects: agree to use a reliable method of birth control

               -  Female subjects: women not of child-bearing potential due to surgical
                  sterilization (at least 6 weeks post-surgical bilateral oophorectomy with or
                  without hysterectomy or tubal ligation) confirmed by medical history, or
                  menopause

               -  Up to third generation Japanese, that is defined as all of the subject's
                  biological grandparents are of exclusive Japanese descent and have been born in
                  Japan

               -  Are ambulatory and able to perform a stair climb test

               -  Have clinical laboratory tests within normal reference range for the population
                  or investigator site, or results with acceptable deviations that are judged to be
                  not clinically significant by the investigator

               -  Have venous access sufficient to allow for blood sampling and/or administration
                  of investigational product for intravenous administration

        Exclusion Criteria:

          -  Single dose cohort

               -  Intend to use over the counter or prescription medication within 14 days prior to
                  dosing through 2 months after dosing except for thyroid replacement hormones or
                  non-absorbed topical preparations per investigator instructions

               -  Abnormal supine blood pressure defined as diastolic blood pressure > 90
                  millimeters of mercury (mmHg) and/or systolic blood pressure >140 mmHg

          -  Multiple dose cohort

               -  If taking medications, subjects who have not been stable for at least 3 months,
                  or the time required to produce stable effects of the drug

               -  Abnormal supine blood pressure defined as >100 mmHg and/or systolic blood
                  pressure >160 mmHg

          -  All subjects

               -  Have known allergies to LY2495655, related compounds or any components of the
                  formulation

               -  Have a history or presence of cardiovascular, respiratory (including moderate to
                  severe restrictive lung disease and obstructive disease, chronic bronchitis, and
                  those with symptomatic asthma), hepatic, renal, gastrointestinal, endocrine,
                  hematological, or neurological disorders capable of constituting a risk when
                  taking the study medication or of interfering with the interpretation of data

               -  Have a history of seizures or convulsions, excluding febrile convulsions in
                  childhood

               -  Subjects with underlying muscle disease or a history of muscle disease (for
                  example, polymyositis or rhabdomyolysis)

               -  Evidence or recent history of significant active psychiatric disease such as
                  schizophrenia, depression, or bipolar disorder

               -  Recent immobilization or major trauma to the legs within 6 months

               -  Knee or hip replacement or lower extremity amputation

               -  Participate in, or have participated within 3 months of study drug
                  administration, a regular resistance training program or plan to participate in
                  an exercise program during the study

               -  Actively working in a physically demanding profession

               -  Have contraindications for the Magnetic Resonance Imaging (MRI) scan

               -  Tattoos on the right leg if the tattoos are at least 20 years old and may have
                  iron-containing pigments

               -  Electrocardiogram (ECG) considered outside the normal limits for the study
                  population by the investigator and relevant for interpretation or indicating
                  cardiac disease

               -  Clinically significant abnormality in neurologic or neurocognitive examinations
                  at screening