NCT03188510

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 total duration of the clinical trial will be approximately 13 weeks, not including screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2017

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

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
6.2 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

June 13, 2017

Results QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828

    PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC\[0-tlast\]) of LY3074828 was evaluated. Unit of measure expansion: microgram\*day per milliliter per milligram (µg\*day/mL/mg).

    Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose

  • PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828

    PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC\[0-∞\]) of LY3074828 was evaluated.

    Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose

Secondary Outcomes (1)

  • Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)

    Predose Day 1 Through Day 85

Study Arms (3)

Reference: 250 mg LY3074828

EXPERIMENTAL

250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections

Biological: LY3074828

Test 1: 250 mg LY3074828

EXPERIMENTAL

250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes

Biological: LY3074828

Test 2: 500 mg LY3074828

EXPERIMENTAL

500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes

Biological: LY3074828

Interventions

LY3074828BIOLOGICAL

Administered SC

Reference: 250 mg LY3074828Test 1: 250 mg LY3074828Test 2: 500 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 1 month 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Dallas, Texas, 75247, 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
OTHER
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

June 13, 2017

First Posted

June 15, 2017

Study Start

June 30, 2017

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

January 25, 2024

Results First Posted

January 25, 2024

Record last verified: 2023-05

Locations

US(1)