A Study of Two Formulations of Ixekizumab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ixekizumab

• Registration Number: NCT04259346
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Primary Completion: 2021-02-19
• Study Completion: 2021-02-19
• Status Verified: 2022-02-01
• Results First Submitted: 2022-02-14
• Results First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Results First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ixekizumab (Reference)	Ixekizumab	Approved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).
Ixekizumab (Test)	Ixekizumab	Test formulation of 80 mg ixekizumab administered as a SC injection via AI.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) 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	PK: Cmax of ixekizumab was evaluated
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) 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	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.
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) 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	Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.

Trial Locations

Locations (3)

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States

Covance Dallas; 🇺🇸 Dallas, Texas, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States