Study of LY3074828 in Healthy Participants

NCT03748940 | Completed Phase 1 FDA Drug

• 3 other identifiers: 17097I9O-MC-AABC2018-000773-68
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Pain Score

  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).

  Within 1-minute post injection

Study Arms (5)

Part A: Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously (SC)

Drug: Placebo

Part A: LY3074828

EXPERIMENTAL

LY3074828 administered SC

Drug: LY3074828

Part B: Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Part B: LY3074828

EXPERIMENTAL

LY3074828 administered SC

Drug: LY3074828

Part B: LY900021

EXPERIMENTAL

LY900021 (LY3074828 + LY9999QS) administered SC

Drug: LY900021

Interventions

LY3074828 DRUG

Administered SC

Part A: LY3074828; Part B: LY3074828

Placebo DRUG

Administered SC

Part A: Placebo; Part B: Placebo

LY900021 DRUG

Administered SC

Part B: LY900021

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Ltd

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

mirikizumab

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: November 21, 2018
• Study Start: October 10, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)