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Completed

NCT Number: NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ixekizumab

Drug

Administered SC.

Other names: LY2439821

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab

    Time frame: 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

  2. PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab

    Time frame: 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.

  3. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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