Study of Ixekizumab in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Biological: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03848403

I1F-MC-RHCS (Other Identifier)

17139 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Ixekizumab (Reference)

Experimental group

Description:

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

Treatment:

Biological: Ixekizumab

Ixekizumab (Test 1)

Experimental group

Description:

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

Treatment:

Biological: Ixekizumab

Ixekizumab (Test 2)

Experimental group

Description:

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

Treatment:

Biological: Ixekizumab