A Study of Two Formulations of LY3074828 in Healthy Participants

May 5, 2023 updated by: Eli Lilly and Company

A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Clinical Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Healthy participants.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test 1: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter [mg/mL]) administered subcutaneously (SC) via an auto-injector (AI) in arm.
Biological: LY3074828
Administered SC
Device: Auto-injector (AI)
AI to administer LY3074828
Experimental: Test 2: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Biological: LY3074828
Administered SC
Device: Auto-injector (AI)
AI to administer LY3074828
Experimental: Test 3: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
Biological: LY3074828
Administered SC
Device: Auto-injector (AI)
AI to administer LY3074828
Experimental: Reference 1: 250 mg LY3074828

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.

The second injection was administered 20 (±2) minutes after the first injection.
Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Drug: LY3074828
Administered SC
Experimental: Reference 2: 250 mg LY3074828

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.

The second injection was administered 20 (±2) minutes after the first injection.
Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Drug: LY3074828
Administered SC
Experimental: Reference 3: 250 mg LY3074828

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.

The second injection was administered 20 (±2) minutes after the first injection.
Device: Prefilled syringe (PFS)
PFS to administer LY3074828
Drug: LY3074828
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device
Time Frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Cmax of LY3074828
Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device
Time Frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Visual Analogue Scale (VAS) Pain Assessment by Device
Time Frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Time Frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Day 1: 1, 5 (±1.5) and 15 (±2) minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Actual)

January 25, 2019

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16618
  • I6T-MC-AMAR (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on LY3074828

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe