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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: LY3074828; Biological: LY900021

• Registration Number: NCT03220126
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-14
• Study Start: 2017-07-17
• Study First Posted: 2017-07-18
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3074828 - Treatment 1	LY3074828	Single intravenous (IV) dose of LY3074828
LY900021 - Treatment 3	LY900021	Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)
LY900021 - Treatment 4	LY900021	Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)
LY900021 - Treatment 2	LY900021	Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828	Baseline through Day 85	PK: AUC of LY3074828

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇬🇧 Leeds, United Kingdom