A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants

NCT03220126 | Completed Phase 1 FDA Drug

• 3 other identifiers: 16861I9O-MC-AABA2017-001242-10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations 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 total duration of the clinical trial will be approximately 13 weeks, not including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828

  PK: AUC of LY3074828

  Baseline through Day 85

Study Arms (4)

LY3074828 - Treatment 1

EXPERIMENTAL

Single intravenous (IV) dose of LY3074828

Biological: LY3074828

LY900021 - Treatment 2

EXPERIMENTAL

Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS)

Biological: LY900021

LY900021 - Treatment 3

EXPERIMENTAL

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Biological: LY900021

LY900021 - Treatment 4

EXPERIMENTAL

Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)

Biological: LY900021

Interventions

LY3074828 BIOLOGICAL

Administered IV

LY3074828 - Treatment 1

LY900021 BIOLOGICAL

Administered SC

LY900021 - Treatment 2; LY900021 - Treatment 3; LY900021 - Treatment 4

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
• Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

You may not qualify if:

• 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 1 month of screening, or intend to 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 humanised monoclonal antibodies
• Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever 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)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Leeds, 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: NONE
• Masking Details: Open
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatments 2 and 3 of LY900021 will be administered in parallel with LY3074828. Treatments 2, 3, and 4 of LY900021 will be administered sequentially pending a safety review after administration of Treatments 2 and 3.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: July 17, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

GB (1)