A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: LY3316531 - IV; LY3316531 - SC; Placebo - IV
Intervention description: Administered IV.; Administered SC.; Administered IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate how well LY3316531 is tolerated and what side
      effects may occur in healthy participants and participants with psoriasis. The study drug
      will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into
      a vein in the arm).

      This is a three-part study. Participants will enroll in only one part. Parts A and B are for
      healthy participants and Part C is for participants with psoriasis. Participation could last
      between 16 and 57 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Participants

               -  Are overtly healthy males or females, as determined by medical history and
                  physical examination

               -  Females must be of non-childbearing potential

               -  Are between 18 and 64 years of age, inclusive, at screening

               -  Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²)
                  inclusive

               -  Are reliable and willing to make themselves available for the duration of the
                  study and are willing to follow study procedures

          -  Psoriasis Participants:

               -  Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic
                  psoriasis vulgaris for at least 6 months prior to baseline

               -  Meet psoriasis disease activity criteria

               -  Are at least 18 years of age

               -  Have a minimum body weight of 50 kilograms (kg)

        Exclusion Criteria:

          -  Healthy and Psoriasis Participants

               -  Have known or ongoing neuropsychiatric disorders

               -  Have received live vaccine(s) (included attenuated live vaccines) within 28 days
                  of screening or intend to during the study

               -  Have had any malignancy within the past 5 years except for basal cell or squamous
                  cell epithelial carcinomas of the skin that have been resected with no subsequent
                  evidence of recurrence for at least 3 years prior to screening and cervical
                  carcinoma in situ with no evidence of recurrence within 5 years prior to baseline

               -  Show evidence of active or latent tuberculosis (TB)

               -  Have presence of significant uncontrolled cerebro-cardiovascular, respiratory,
                  hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or
                  neuropsychiatric disorders or abnormal laboratory values at screening that, in
                  the opinion of the investigator, pose an unacceptable risk to the participant if
                  participating in the study or of interfering with the interpretation of data

          -  Psoriasis Participants Only:

               -  Have received treatment with biologic therapies for psoriasis (such as monoclonal
                  antibodies, including marketed or investigational biologic therapy)

               -  Prior or current use of biologics for indications other than psoriasis may be
                  allowed with sponsor approval

               -  Have received systemic nonbiologic psoriasis therapy within 28 days of baseline

               -  Have received topical psoriasis treatment within 14 days of baseline