A Study of Two Formulations of Ixekizumab in Healthy Participants

Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects

The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
    • Miami, Florida, United States, 33143
      • Miami Research Associates
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are healthy male 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ixekizumab (Reference); Approved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).	Drug: Ixekizumab; Administered SC.; Other Names: LY2439821
EXPERIMENTAL: Ixekizumab (Test); Test formulation of 80 mg ixekizumab administered as a SC injection via AI.	Drug: 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	PK: Cmax of ixekizumab was evaluated	Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, 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 8, Day 11, Day 15, Day 22, Day 29, 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 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2020
• Primary Completion (ACTUAL): February 19, 2021
• Study Completion (ACTUAL): February 19, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 17151; I1F-MC-RHCU (OTHER: 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