A Study of LY3375880 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3375880 SC; Drug: LY3375880 IV; Drug: Placebo SC; Drug: Placebo IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03343587

I9N-MC-FCAA (Other Identifier)

16833

Details and patient eligibility

About

The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.

This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy males or females, as determined by medical history and physical examination
• Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

• Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
• Are women who are of childbearing potential or who are lactating

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

LY3375880 Single Dose

Experimental group

Description:

Single dose of LY3375880 administered IV or SC

Treatment:

Drug: LY3375880 SC

Drug: LY3375880 IV

Placebo Single Dose

Placebo Comparator group

Description:

Single dose of placebo administered IV or SC

Treatment:

Drug: Placebo IV

Drug: Placebo SC

LY3375880 Multiple Dose

Experimental group

Description:

Multiple doses of LY3375880 administered IV or SC

Treatment:

Drug: LY3375880 SC

Drug: LY3375880 IV

Placebo Multiple Dose

Placebo Comparator group

Description:

Multiple doses of placebo administered IV or SC

Treatment:

Drug: Placebo IV

Drug: Placebo SC