A Study of Two Formulations of LY3074828 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3074828; Device: Auto-injector (AI); Device: Prefilled syringe (PFS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03662100

I6T-MC-AMAR (Other Identifier)

16618

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 as different formulations. The tolerability of LY3074828 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 study will last about 12 weeks, not including screening.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Healthy participants.

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 6 patient groups

Test 1: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter \[mg/mL\]) administered subcutaneously (SC) via an auto-injector (AI) in arm.

Treatment:

Device: Auto-injector (AI)

Test 2: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.

Treatment:

Device: Auto-injector (AI)

Test 3: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.

Treatment:

Device: Auto-injector (AI)

Reference 1: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. The second injection was administered 20 (±2) minutes after the first injection.

Treatment:

Drug: LY3074828

Device: Prefilled syringe (PFS)

Drug: LY3074828

Reference 2: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection.

Treatment:

Drug: LY3074828

Device: Prefilled syringe (PFS)

Drug: LY3074828

Reference 3: 250 mg LY3074828

Experimental group

Description:

Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection.

Treatment:

Drug: LY3074828

Device: Prefilled syringe (PFS)

Drug: LY3074828