A Study of Injections of LY3074828 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2019-10-04

Brief Summary

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The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.

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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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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125 mg LY3074828 Prefilled Syringe (PFS)

Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm.

Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.

Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.

Group Type EXPERIMENTAL

LY3074828

Intervention Type DRUG

Administered subcutaneously (SC)

Pre-filled syringe (PFS)

Intervention Type DEVICE

PFS used to administer LY3074828

125 mg LY3074828 Autoinjector (AI)

Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm.

Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.

Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.

Group Type EXPERIMENTAL

LY3074828

Intervention Type DRUG

Administered subcutaneously (SC)

Autoinjector (AI)

Intervention Type DEVICE

AI used to administer LY3074828

Interventions

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LY3074828

Administered subcutaneously (SC)

Intervention Type DRUG

Pre-filled syringe (PFS)

PFS used to administer LY3074828

Intervention Type DEVICE

Autoinjector (AI)

AI used to administer LY3074828

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Must be healthy males or females

Exclusion Criteria

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes