NCT03662100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2018

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
5 years until next milestone

Results Posted

Study results publicly available

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

September 5, 2018

Results QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device

    Pharmacokinetics: Cmax of LY3074828

    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 by Device

    Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828

    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

  • Visual Analogue Scale (VAS) Pain Assessment by Device

    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.

    Day 1: 1, 5 (±1.5) and 15 (±2) minutes

  • Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location

    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.

    Day 1: 1, 5 (±1.5) and 15 (±2) minutes

Study Arms (6)

Test 1: 250 mg LY3074828

EXPERIMENTAL

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.

Biological: LY3074828Device: Auto-injector (AI)

Test 2: 250 mg LY3074828

EXPERIMENTAL

Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.

Biological: LY3074828Device: Auto-injector (AI)

Test 3: 250 mg LY3074828

EXPERIMENTAL

Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.

Biological: LY3074828Device: Auto-injector (AI)

Reference 1: 250 mg LY3074828

EXPERIMENTAL

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.

Drug: LY3074828Device: Prefilled syringe (PFS)

Reference 2: 250 mg LY3074828

EXPERIMENTAL

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.

Drug: LY3074828Device: Prefilled syringe (PFS)

Reference 3: 250 mg LY3074828

EXPERIMENTAL

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.

Drug: LY3074828Device: Prefilled syringe (PFS)

Interventions

LY3074828BIOLOGICAL

Administered SC

Test 1: 250 mg LY3074828Test 2: 250 mg LY3074828Test 3: 250 mg LY3074828
Auto-injector (AI)DEVICE

AI to administer LY3074828

Test 1: 250 mg LY3074828Test 2: 250 mg LY3074828Test 3: 250 mg LY3074828
Prefilled syringe (PFS)DEVICE

PFS to administer LY3074828

Reference 1: 250 mg LY3074828Reference 2: 250 mg LY3074828Reference 3: 250 mg LY3074828

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

September 6, 2018

Primary Completion

January 25, 2019

Study Completion

January 25, 2019

Last Updated

January 25, 2024

Results First Posted

January 25, 2024

Record last verified: 2023-05-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)