A Study of LY4302814 in Healthy Participants

Purpose

The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Are overtly healthy as determined by medical evaluation. - Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator. - Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive. - Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Adult participants in Singapore: - Are 21 years of age or older.

Exclusion Criteria

  • Evidence or history of clinically significant conditions. - Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis. - Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc). - Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV. - Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies. - Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study. - Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions. - Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4302814 IV 		LY4302814 administered intravenously (IV)
  • Drug: LY4302814
    Administered IV
Placebo Comparator
Placebo IV 		Placebo administered IV
  • Drug: Placebo
    Administered IV
Experimental
LY4302814 SC 		LY4302814 administered subcutaneously (SC)
  • Drug: LY4302814
    Administered SC
Placebo Comparator
Placebo SC 		Placebo administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Fortrea Clinical Research Unit
Daytona Beach, Florida 32117
Contact:
866-429-3700

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com