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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: LY900021; Biological: LY3074828

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220126

16861

2017-001242-10 (EudraCT Number)

I9O-MC-AABA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

LY3074828 - Treatment 1

Experimental group

Description:

Single intravenous (IV) dose of LY3074828

Treatment:

Biological: LY3074828

LY900021 - Treatment 2

Experimental group

Description:

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

Treatment:

Biological: LY900021

LY900021 - Treatment 3

Experimental group

Description:

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Treatment:

Biological: LY900021

LY900021 - Treatment 4

Experimental group

Description:

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Treatment:

Biological: LY900021