A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2018-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations 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 total duration of the clinical trial will be approximately 13 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

Healthy

COMPLETED PHASE1

A Study of Two Formulations of LY3074828 in Healthy Participants

NCT03662100

Healthy

COMPLETED PHASE1

Study of LY3039478 in Healthy Participants

NCT02906618

Healthy

COMPLETED PHASE1

A Study to Compare Two Forms of LY2608204 in Healthy People

NCT01313286

Healthy Volunteers

COMPLETED PHASE1

A Study of LY3314814 in Healthy Participants

NCT03222427

Healthy

COMPLETED PHASE1

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.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatments 2 and 3 of LY900021 will be administered in parallel with LY3074828. Treatments 2, 3, and 4 of LY900021 will be administered sequentially pending a safety review after administration of Treatments 2 and 3.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Open

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3074828 - Treatment 1

Single intravenous (IV) dose of LY3074828

Group Type EXPERIMENTAL

LY3074828

Intervention Type BIOLOGICAL

Administered IV

LY900021 - Treatment 2

Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS)

Group Type EXPERIMENTAL

LY900021

Intervention Type BIOLOGICAL

Administered SC

LY900021 - Treatment 3

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Group Type EXPERIMENTAL

LY900021

Intervention Type BIOLOGICAL

Administered SC

LY900021 - Treatment 4

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Group Type EXPERIMENTAL

LY900021

Intervention Type BIOLOGICAL

Administered SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3074828

Administered IV

Intervention Type BIOLOGICAL

LY900021

Administered SC

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have venous access sufficient to allow for blood sampling and administration of investigational product
* Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

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 1 month of screening, or intend to 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 humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever 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