Study of LY3074828 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3074828; Drug: LY900021

Study type: Interventional

Funder types: Industry

Identifiers

NCT03748940

2018-000773-68 (EudraCT Number)

17097

I9O-MC-AABC (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").

The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.

Enrollment: 60 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

Exclusion criteria

• Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per 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 receive 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 humanized monoclonal antibodies
• Must not have clinically significant multiple or severe drug allergies, 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Part A: Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously (SC)

Treatment:

Drug: Placebo

Part A: LY3074828

Experimental group

Description:

LY3074828 administered SC

Treatment:

Drug: LY3074828

Part B: Placebo

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

Part B: LY3074828

Experimental group

Description:

LY3074828 administered SC

Treatment:

Drug: LY3074828

Part B: LY900021

Experimental group

Description:

LY900021 (LY3074828 + LY9999QS) administered SC

Treatment:

Drug: LY900021