A Study of Injections of LY3074828 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Autoinjector (AI); Device: Pre-filled syringe (PFS); Drug: LY3074828

Study type: Interventional

Funder types: Industry

Identifiers

NCT03886948

16780

I6T-MC-AMBE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be healthy males or females

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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

125 mg LY3074828 Prefilled Syringe (PFS)

Experimental group

Description:

Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm. Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.

Treatment:

Drug: LY3074828

Device: Pre-filled syringe (PFS)

125 mg LY3074828 Autoinjector (AI)

Experimental group

Description:

Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm. Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.

Treatment:

Drug: LY3074828

Device: Autoinjector (AI)