Study of Ixekizumab in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2019-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Ixekizumab in Healthy Participants

NCT03848416

Healthy

COMPLETED PHASE1

A Study of Two Formulations of Ixekizumab in Healthy Participants

NCT04259346

Healthy

COMPLETED PHASE1

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

NCT02543918

Healthy

COMPLETED PHASE1

A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

NCT04840901

Healthy

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

NCT04828343

Healthy Study Participants

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ixekizumab (Reference)

Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type BIOLOGICAL

Administered SC

Ixekizumab (Test 1)

Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type BIOLOGICAL

Administered SC

Ixekizumab (Test 2)

Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type BIOLOGICAL

Administered SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ixekizumab

Administered SC

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY2439821

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male participants or female participants who agree not to get pregnant
* Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant 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
* Have dullness or loss of sensitivity on either side of your abdomen
* Have any condition that could affect pain perception from an injection
* 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 excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes