A Study of Ixekizumab in Healthy Participants

Relative Bioavailability of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation in Healthy Subjects

The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Ixekizumab

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male participant or female participant who agree to not become pregnant
• Are male participant or female participants with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

Exclusion Criteria:

• Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
• Are allergic or hypersensitive to the study medicine
• Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
• Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
• Show evidence of active or latent tuberculosis (TB)
• Presence of significant neuropsychiatric disorder or a recent history of depression
• Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant, if participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ixekizumab (Reference); Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.	Biological: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: Ixekizumab (Test 1); Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.	Biological: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: Ixekizumab (Test 2); Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.	Biological: Ixekizumab; Administered SC; Other Names: LY2439821

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab	Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab	Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab	Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC[0-tlast]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.	Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab.	Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab.	Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 17140; I1F-MC-RHCT (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No