A Study of Injections of LY3074828 in Healthy Participants

Eli Lilly and Company66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LY3074828DRUG

Administered subcutaneously (SC)

Pre-filled syringe (PFS)DEVICE

PFS used to administer LY3074828

Autoinjector (AI)DEVICE

AI used to administer LY3074828

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Inc

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828

Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85

PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration

PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration

Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828

PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828

Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85

Visual Analog Scale (VAS) Pain Score by Device

The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).

Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes

Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location

Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes

Data from ClinicalTrials.gov

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