Study of LY3074828 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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-06-18

Brief Summary

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The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").

The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.

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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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Placebo

Placebo administered subcutaneously (SC)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Part A: LY3074828

LY3074828 administered SC

Group Type EXPERIMENTAL

LY3074828

Intervention Type DRUG

Administered SC

Part B: Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Part B: LY3074828

LY3074828 administered SC

Group Type EXPERIMENTAL

LY3074828

Intervention Type DRUG

Administered SC

Part B: LY900021

LY900021 (LY3074828 + LY9999QS) administered SC

Group Type EXPERIMENTAL

LY900021

Intervention Type DRUG

Administered SC

Interventions

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LY3074828

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

LY900021

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Have venous access sufficient to allow for blood sampling and administration of investigational product

Exclusion Criteria

* Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per 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 1 month of screening or intend to receive during the study
* Must not be immunocompromised
* Must not have known hypersensitivity to hyaluronidases
* 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 dosing
* Must not have significant allergies to humanized monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, 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