A Study of Two Formulations of LY3074828 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3074828; Device: Prefilled syringe (PFS); Device: Auto-injector (AI)

• Registration Number: NCT03662100
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study Start: 2018-09-06
• Study First Posted: 2018-09-07
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2023-05-01
• Results First Submitted: 2023-05-05
• Results First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Results First Posted: 2024-01-25
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Healthy participants.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 1: 250 mg LY3074828	LY3074828	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.
Test 2: 250 mg LY3074828	LY3074828	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828	LY3074828	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
Reference 1: 250 mg LY3074828	LY3074828	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.
Reference 1: 250 mg LY3074828	Prefilled syringe (PFS)	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.
Test 1: 250 mg LY3074828	Auto-injector (AI)	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.
Test 2: 250 mg LY3074828	Auto-injector (AI)	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828	Auto-injector (AI)	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
Reference 2: 250 mg LY3074828	LY3074828	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.
Reference 2: 250 mg LY3074828	Prefilled syringe (PFS)	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.
Reference 3: 250 mg LY3074828	Prefilled syringe (PFS)	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.
Reference 3: 250 mg LY3074828	LY3074828	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device	Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose	Pharmacokinetics: Cmax of LY3074828
Visual Analogue Scale (VAS) Pain Assessment by Device	Day 1: 1, 5 (±1.5) and 15 (±2) minutes	The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device	Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose	Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location	Day 1: 1, 5 (±1.5) and 15 (±2) minutes	The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States