LY3316531 - IV
DrugAdministered IV.
NCT Number: NCT03418493
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.
Looking for future studies?
Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Parexel Early Phase Unit at Glendale, Glendale, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV.
Administered SC.
Administered IV.
Time frame: Pre-dose up to 1 year after administration of study drug
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:
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
PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
PK: Cmax of LY3316531 following the Day 57 dose.
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
PK: Cmax of LY3316531.
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
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.
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
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Eli Lilly and Company
Industry
A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04728165
Psoriasis, Skin Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01778569
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05295979
Psoriasis, Skin Diseases
Hong Kong
View Trial DetailsNCT07712731
Psoriasis, Skin Diseases
Baotou, China
View Trial Details