A Study of LY3053102 in Healthy Participants

Phase 1

Completed

Brief Summary: The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Recruitment & Eligibility

Inclusion Criteria

Normal blood pressure
Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria

Had known allergies to LY3053102 or related compounds
Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
Heavy smokers (more than 10 cigarettes a day)

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.
LY3053102	LY3053102	A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs	Baseline through Day 31	A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102	Time 0 to 168 hours after study drug administration on Day 1	AUC curve from time 0 to 168 hours postdose of LY3053102.
PK: Observed Maximum Drug Concentration (Cmax) of LY3053102	Time 0 to 168 hours after study drug administration on Day 1	Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.
Number of Participants Who Developed Anti-LY3053102 Antibodies	Baseline, up to Day 31	LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a \>=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Singapore, Singapore