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Completed

NCT Number: NCT03886948

A Study of Injections of LY3074828 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3074828

Drug

Administered subcutaneously (SC)

Pre-filled Syringe (PFS)

Device

PFS used to administer LY3074828

Autoinjector (AI)

Device

AI used to administer LY3074828

Primary outcomes

  1. 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

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

  2. 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 Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration

  3. 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

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

  4. Visual Analog Scale (VAS) Pain Score by Device

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

    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).

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

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

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 1-mL Autoinjector in Healthy Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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