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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
63
Administered IV.
Administered SC.
Administered IV.
Parexel Early Phase Unit at Glendale
Glendale, California, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Time frame: Pre-dose up to 1 year after administration of study drug
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."
Time frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531 following the Day 57 dose.
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531.
Time frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
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Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Time frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Time frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose