A Study of Two Formulations of LY3074828 in Healthy Participants
NCT ID: NCT03662100
Last Updated: 2024-01-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2018-09-06
2019-01-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Two Different Formulations of LY3074828 in Healthy Participants
NCT03188510
A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants
NCT03220126
Study of LY3039478 in Healthy Participants
NCT02906618
A Study of How the Body Absorbs LY3537031
NCT07202871
A Study of LY3866288 in Healthy Participants
NCT06641037
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
LY3074828
Administered SC
Auto-injector (AI)
AI to administer LY3074828
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.
LY3074828
Administered SC
Auto-injector (AI)
AI to administer LY3074828
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.
LY3074828
Administered SC
Auto-injector (AI)
AI to administer LY3074828
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.
LY3074828
Administered SC
Prefilled syringe (PFS)
PFS to administer LY3074828
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.
LY3074828
Administered SC
Prefilled syringe (PFS)
PFS to administer LY3074828
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.
LY3074828
Administered SC
Prefilled syringe (PFS)
PFS to administer LY3074828
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LY3074828
Administered SC
LY3074828
Administered SC
Auto-injector (AI)
AI to administer LY3074828
Prefilled syringe (PFS)
PFS to administer LY3074828
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Covance Clinical Research Inc
Daytona Beach, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I6T-MC-AMAR
Identifier Type: OTHER
Identifier Source: secondary_id
16618
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.