Study of LY3074828 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3074828; Drug: Placebo; Drug: LY900021

• Registration Number: NCT03748940
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

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: 2018-09-28
• Study Start: 2018-10-10
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Have venous access sufficient to allow for blood sampling and administration of investigational product

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: LY3074828	LY3074828	LY3074828 administered SC
Part B: LY3074828	LY3074828	LY3074828 administered SC
Part A: Placebo	Placebo	Placebo administered subcutaneously (SC)
Part B: Placebo	Placebo	Placebo administered SC
Part B: LY900021	LY900021	LY900021 (LY3074828 + LY9999QS) administered SC

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Score	Within 1-minute post injection	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 scale from 0 mm (no pain) to 100 mm (severe pain).

Trial Locations

Locations (1)

Covance Clinical Research Ltd; 🇬🇧 Leeds, West Yorkshire, United Kingdom