A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Part A is a crossover design. Part B is a parallel design.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: LY3375880 Formulation A

LY3375880 Formulation A administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Autoinjector (AI)

Intervention Type DEVICE

AI used to administer LY3375880 or Buffer Matrix

Part A: LY3375880 Formulation B

LY3375880 Formulation B administered subcutaneously SC.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Autoinjector (AI)

Intervention Type DEVICE

AI used to administer LY3375880 or Buffer Matrix

Part A: LY3375880 Formulation C

LY3375880 Formulation C administered SC.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Autoinjector (AI)

Intervention Type DEVICE

AI used to administer LY3375880 or Buffer Matrix

Part A: Positive Control

Positive Control (buffer matrix, only) administered SC.

Group Type PLACEBO_COMPARATOR

Buffer Matrix (No LY3375880)

Intervention Type DRUG

Administered SC

Autoinjector (AI)

Intervention Type DEVICE

AI used to administer LY3375880 or Buffer Matrix

Part B: LY3375880 Test 1

LY3375880 Test 1 Formulation administered SC.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Manual Syringe

Intervention Type DEVICE

Manual syringe used to inject LY3375880

Part B: LY3375880 Test 2

LY3375880 Test 2 Formulation administered SC.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Manual Syringe

Intervention Type DEVICE

Manual syringe used to inject LY3375880

Part B: LY3375880 Test 3

LY3375880 Test 3 Formulation administered SC.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Manual Syringe

Intervention Type DEVICE

Manual syringe used to inject LY3375880

Interventions

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LY3375880

Administered SC

Intervention Type DRUG

Buffer Matrix (No LY3375880)

Administered SC

Intervention Type DRUG

Autoinjector (AI)

AI used to administer LY3375880 or Buffer Matrix

Intervention Type DEVICE

Manual Syringe

Manual syringe used to inject LY3375880

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes