A Study of Two Formulations of Ixekizumab in Healthy Participants
Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects
2 other identifiers
interventional
245
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2020
Longer than P75 for phase_1 healthy
4 active sites
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
February 5, 2020
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2021
CompletedResults Posted
Study results publicly available
April 8, 2022
CompletedApril 8, 2022
February 1, 2022
1 year
February 5, 2020
February 14, 2022
February 14, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Ixekizumab (Reference)
EXPERIMENTALApproved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).
Ixekizumab (Test)
EXPERIMENTALTest formulation of 80 mg ixekizumab administered as a SC injection via AI.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Covance Clinical Research Inc
Daytona Beach, Florida, 32117, United States
Miami Research Associates
Miami, Florida, 33143, United States
Covance Dallas
Dallas, Texas, 75247, United States
Covance Clinical Research Inc
Madison, Wisconsin, 53704, United States
Related Publications (1)
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.
PMID: 35449322DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 6, 2020
Study Start
February 5, 2020
Primary Completion
February 19, 2021
Study Completion
February 19, 2021
Last Updated
April 8, 2022
Results First Posted
April 8, 2022
Record last verified: 2022-02-01
Data Sharing
- IPD Sharing
- Will not share