A Safety Study of LY3462817 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: LY3462817 SC; Biological: LY3462817 IV; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03715192

17089

J1A-MC-KDAB (Other Identifier)

Details and patient eligibility

About

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.

Enrollment: 64 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy male or a female who cannot get pregnant
• Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
• Weight at least 45 kilograms (kg)

Exclusion criteria

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have cancer or a malignant disease in the past 5 years
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Are unwilling to receive study drug administration by injections or through the veins

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups, including a placebo group

LY3462817 - IV

Experimental group

Description:

Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants

Treatment:

Biological: LY3462817 IV

Placebo

Placebo Comparator group

Description:

Normal saline administered as a single IV infusion in healthy participants

Treatment:

Drug: Placebo

LY3462817 - SC

Experimental group

Description:

Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants

Treatment:

Biological: LY3462817 SC