A Study of Injections of LY3074828 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3074828; Device: Pre-filled syringe (PFS); Device: Autoinjector (AI)

• Registration Number: NCT03886948
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-03-27
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Results First Submitted: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

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

Inclusion Criteria

• Must be healthy males or females

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
125 mg LY3074828 Prefilled Syringe (PFS)	LY3074828	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.
125 mg LY3074828 Prefilled Syringe (PFS)	Pre-filled syringe (PFS)	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.
125 mg LY3074828 Autoinjector (AI)	LY3074828	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.
125 mg LY3074828 Autoinjector (AI)	Autoinjector (AI)	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.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration	Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85	PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration
Visual Analog Scale (VAS) Pain Score by Device	Day 1: 1, 5 (±1.5) and 15 (±2) minutes	The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828	Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828	Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85	PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location	Day 1: 1, 5 (±1.5) and 15 (±2) minutes	The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).

Trial Locations

Locations (1)

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