A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3375880; Device: Autoinjector (AI); Drug: Buffer Matrix (No LY3375880); Device: Manual Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03913260

17212 (Other Identifier)

I9N-MC-FCAC (Other Identifier)

Details and patient eligibility

About

The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.

Enrollment: 83 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
• Females who are not of child-bearing potential
• Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
• 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
• Have participated or are currently enrolled in clinical trials with LY3375880
• Have infections or evidence of infections
• Are pregnant, lactating or breast feeding

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 7 patient groups, including a placebo group

Part A: LY3375880 Formulation A

Experimental group

Description:

LY3375880 Formulation A administered subcutaneously (SC).

Treatment:

Drug: LY3375880

Device: Autoinjector (AI)

Part A: LY3375880 Formulation B

Experimental group

Description:

LY3375880 Formulation B administered subcutaneously SC.

Treatment:

Drug: LY3375880

Device: Autoinjector (AI)

Part A: LY3375880 Formulation C

Experimental group

Description:

LY3375880 Formulation C administered SC.

Treatment:

Drug: LY3375880

Device: Autoinjector (AI)

Part A: Positive Control

Placebo Comparator group

Description:

Positive Control (buffer matrix, only) administered SC.

Treatment:

Device: Autoinjector (AI)

Drug: Buffer Matrix (No LY3375880)

Part B: LY3375880 Test 1

Experimental group

Description:

LY3375880 Test 1 Formulation administered SC.

Treatment:

Drug: LY3375880

Device: Manual Syringe

Part B: LY3375880 Test 2

Experimental group

Description:

LY3375880 Test 2 Formulation administered SC.

Treatment:

Drug: LY3375880

Device: Manual Syringe

Part B: LY3375880 Test 3

Experimental group

Description:

LY3375880 Test 3 Formulation administered SC.

Treatment:

Drug: LY3375880

Device: Manual Syringe